Low Acuity Dressing With Integral Pump

ABSTRACT

Systems, assemblies, and methods for providing negative-pressure therapy to a tissue site are described. The system can include an absorbent and a sealing layer configured to cover the absorbent. The system can also include a blister fluidly coupled to the absorbent. The blister may have a collapsed position and an expanded position. A first check valve may be fluidly coupled to the absorbent and the blister and configured to prevent fluid flow from the blister into the absorbent if the blister is moved from the expanded position to the collapsed position. A second check valve may be fluidly coupled to the blister and the ambient environment and configured to prevent fluid flow from the ambient environment into the blister if the blister is moved from the collapsed position to the expanded position.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.15/571,238 filed Nov. 1, 2017, which is a National Stage entry ofPCT/US16/31397 filed May 8, 2016, which claims the benefit, under 35 USC119(e), of the filing of U.S. Provisional Patent Application No.62/159,110, entitled “Low-Acuity Dressing with Integral Pump,” filed May8, 2015, which is incorporated herein by reference for all purposes.

TECHNICAL FIELD

The invention set forth in the appended claims relates generally totissue treatment systems and more particularly, but without limitation,to a dressing having an integral pump for low-acuity tissue sites.

BACKGROUND

Clinical studies and practice have shown that reducing pressure inproximity to a tissue site can augment and accelerate growth of newtissue at the tissue site. The applications of this phenomenon arenumerous, but it has proven particularly advantageous for treatingwounds. Regardless of the etiology of a wound, whether trauma, surgery,or another cause, proper care of the wound is important to the outcome.Treatment of wounds or other tissue with reduced pressure may becommonly referred to as “negative-pressure therapy,” but is also knownby other names, including “negative-pressure wound therapy,”“reduced-pressure therapy,” “vacuum therapy,” and “vacuum-assistedclosure,” for example. Negative-pressure therapy may provide a number ofbenefits, including migration of epithelial and subcutaneous tissues,improved blood flow, and micro-deformation of tissue at a wound site.Together, these benefits can increase development of granulation tissueand reduce healing times.

While the clinical benefits of negative-pressure therapy are widelyknown, the cost and complexity of negative-pressure therapy can be alimiting factor in its application, and the development and operation ofnegative-pressure systems, components, and processes continues topresent significant challenges to manufacturers, healthcare providers,and patients.

BRIEF SUMMARY

New and useful systems, apparatuses, and methods for providingnegative-pressure therapy are set forth in the appended claims.Illustrative embodiments are also provided to enable a person skilled inthe art to make and use the claimed subject matter. For example, asystem for providing negative-pressure therapy to a tissue site isdescribed. The system can include an absorbent and a sealing layerconfigured to cover the absorbent. The system can also include a blisterfluidly coupled to the absorbent. The blister may have a collapsedposition and an expanded position. A first check valve may be fluidlycoupled to the absorbent and the blister and configured to prevent fluidflow from the blister into the absorbent if the blister is moved fromthe expanded position to the collapsed position. A second check valvemay be fluidly coupled to the blister and the ambient environment andconfigured to prevent fluid flow from the ambient environment into theblister if the blister is moved from the collapsed position to theexpanded position.

Alternatively, other example embodiments describe a dressing assemblyfor providing negative-pressure therapy to a tissue site. The dressingassembly can include a pouch and a cover configured to cover the pouch.A negative-pressure source may be fluidly coupled to the pouch. Thenegative-pressure source may have a first position and a secondposition. A first check valve may be fluidly coupled to the pouch andthe negative-pressure source and operable to prevent fluid flow from thenegative-pressure source into the pouch if the negative-pressure sourceis moved from the second position to the first position. A second checkvalve may be fluidly coupled to the negative-pressure source and theambient environment and configured to prevent fluid flow from theambient environment into the negative-pressure source if thenegative-pressure source is moved from the first position to the secondposition.

A method for providing negative-pressure therapy to a tissue site isalso described herein. A dressing assembly may be positioned adjacent tothe tissue site. The dressing assembly may have an absorbent; a sealinglayer configured to cover the absorbent; and a blister fluidly coupledto the absorbent. The blister may have a collapsed position and anexpanded position. A first check valve may be fluidly coupled to theabsorbent and the blister and configured to prevent fluid flow from theblister into the absorbent if the blister is moved from the expandedposition to the collapsed position. A second check valve may be fluidlycoupled to the blister and the ambient environment and configured toprevent fluid flow from the ambient environment into the blister if theblister is moved from the collapsed position to the expanded position.The blister may be compressed from the expanded position to thecollapsed position to evacuate the blister. The blister may expand fromthe collapsed position to the expanded position to draw fluid from theabsorbent.

Objectives, advantages, and a preferred mode of making and using theclaimed subject matter may be understood best by reference to theaccompanying drawings in conjunction with the following detaileddescription of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view of an example embodiment of anegative-pressure therapy system that can provide negative-pressuretherapy in accordance with this specification;

FIG. 2 is a top perspective view illustrating additional details thatmay be associated with an example embodiment of the negative-pressuretherapy system of FIG. 1 in a first position;

FIG. 3 is a top perspective view illustrating additional details thatmay be associated with an example embodiment of the negative-pressuretherapy system of FIG. 1 in a second position;

FIG. 4 is a sectional view of an example embodiment of anothernegative-pressure therapy system that can provide negative-pressuretherapy in accordance with this specification;

FIG. 5 is a sectional view of an example embodiment of anothernegative-pressure therapy system that can provide negative-pressuretherapy in accordance with this specification;

FIG. 6 is a top perspective view illustrating additional details thatmay be associated with an example embodiment of the negative-pressuretherapy system of FIG. 5 in a first position;

FIG. 7 is a top perspective view illustrating additional details thatmay be associated with an example embodiment of the negative-pressuretherapy system of FIG. 5 in a second position;

FIG. 8 is a sectional view of an example embodiment of anothernegative-pressure therapy system that can provide negative-pressuretherapy in accordance with this specification; and

FIG. 9 is a top perspective view illustrating additional details thatmay be associated with an example embodiment of the negative-pressuretherapy system of FIG. 8.

DESCRIPTION OF EXAMPLE EMBODIMENTS

The following description of example embodiments provides informationthat enables a person skilled in the art to make and use the subjectmatter set forth in the appended claims, but may omit certain detailsalready well-known in the art. The following detailed description is,therefore, to be taken as illustrative and not limiting.

The example embodiments may also be described herein with reference tospatial relationships between various elements or to the spatialorientation of various elements depicted in the attached drawings. Ingeneral, such relationships or orientation assume a frame of referenceconsistent with or relative to a patient in a position to receivetreatment. However, as should be recognized by those skilled in the art,this frame of reference is merely a descriptive expedient rather than astrict prescription.

FIG. 1 is a sectional view of an example embodiment of anegative-pressure therapy system 100 that can provide negative-pressuretherapy in accordance with this specification. The negative-pressuretherapy system 100 may include a dressing assembly and a tissueinterface. For example, a tissue interface 108 may be placed in a tissuesite and a dressing assembly 102 may be placed over the tissue site andthe tissue interface 108. The dressing assembly 102 may include a cover103 and a pouch 105 which may be fluidly coupled to a negative-pressuresource 104.

In general, components of the negative-pressure therapy system 100 maybe coupled directly or indirectly. For example, the negative-pressuresource 104 may be directly coupled to the pouch 105 and indirectlycoupled to the tissue site through the pouch 105. Components may befluidly coupled to each other to provide a path for transferring fluids(i.e., liquid and/or gas) between the components.

In some embodiments, components may be fluidly coupled through a tube,such as a tube 140 or a tube 146. A “tube,” as used herein, broadlyrefers to a tube, pipe, hose, conduit, or other structure with one ormore lumina adapted to convey a fluid between two ends. Typically, atube is an elongated, cylindrical structure with some flexibility, butthe geometry and rigidity may vary. In some embodiments, components mayadditionally or alternatively be coupled by virtue of physicalproximity, being integral to a single structure, or being formed fromthe same piece of material. Coupling may also include mechanical,thermal, electrical, or chemical coupling (such as a chemical bond) insome contexts.

In operation, the tissue interface 108 may be placed within, over, on,or otherwise proximate to a tissue site. The cover 103 may be placedover the tissue interface 108 and sealed to tissue near the tissue site.For example, the cover 103 may be sealed to undamaged epidermisperipheral to a tissue site. Thus, the dressing assembly 102 can providea sealed therapeutic environment proximate to a tissue site,substantially isolated from the external environment, and thenegative-pressure source 104 can reduce the pressure in the sealedtherapeutic environment. The sealed therapeutic environment may beformed in the space occupied by the tissue interface 108 and the pouch105. If the tissue interface 108 is not used, the sealed therapeuticenvironment may be formed in the space occupied by the pouch 105 and thetissue site. Negative pressure applied across the tissue site in thesealed therapeutic environment can induce macrostrain and microstrain inthe tissue site, as well as remove exudates and other fluids from thetissue site, which can be collected in the pouch 105 and disposed ofproperly.

The fluid mechanics of using a negative-pressure source to reducepressure in another component or location, such as within a sealedtherapeutic environment, can be mathematically complex. However, thebasic principles of fluid mechanics applicable to negative-pressuretherapy are generally well-known to those skilled in the art, and theprocess of reducing pressure may be described illustratively herein as“delivering,” “distributing,” or “generating” negative pressure, forexample.

In general, exudates and other fluids flow toward lower pressure along afluid path. Thus, the term “downstream” typically implies a position ina fluid path relatively closer to a negative-pressure source, andconversely, the term “upstream” implies a position relatively furtheraway from a negative-pressure source. Similarly, it may be convenient todescribe certain features in terms of fluid “inlet” or “outlet” in sucha frame of reference. This orientation is generally presumed forpurposes of describing various features and components ofnegative-pressure therapy systems herein. However, the fluid path mayalso be reversed in some applications (such as by substituting apositive-pressure source for a negative-pressure source) and thisdescriptive convention should not be construed as a limiting convention.

The term “tissue site” in this context broadly refers to a wound ordefect located on or within tissue, including but not limited to, bonetissue, adipose tissue, muscle tissue, neural tissue, dermal tissue,vascular tissue, connective tissue, cartilage, tendons, or ligaments. Awound may include chronic, acute, traumatic, subacute, and dehiscedwounds, partial-thickness burns, ulcers (such as diabetic, pressure, orvenous insufficiency ulcers), flaps, and grafts, for example. The term“tissue site” may also refer to areas of any tissue that are notnecessarily wounded or defective, but are instead areas in which it maybe desirable to add or promote the growth of additional tissue. Forexample, negative pressure may be used in certain tissue areas to growadditional tissue that may be harvested and transplanted to anothertissue location.

“Negative pressure” generally refers to a pressure less than a localambient pressure, such as the ambient pressure in a local environmentexternal to a sealed therapeutic environment provided by the dressingassembly 102. In many cases, the local ambient pressure may also be theatmospheric pressure at which a tissue site is located. Alternatively,the pressure may be less than a hydrostatic pressure associated withtissue at the tissue site. Unless otherwise indicated, values ofpressure stated herein are gauge pressures. Similarly, references toincreases in negative pressure typically refer to a decrease in absolutepressure, while decreases in negative pressure typically refer to anincrease in absolute pressure.

The tissue interface 108 can be generally adapted to contact a tissuesite. The tissue interface 108 may be partially or fully in contact withthe tissue site. If the tissue site is a wound, for example, the tissueinterface 108 may partially or completely fill the wound, or may beplaced over the wound. The tissue interface 108 may take many forms, andmay have many sizes, shapes, or thicknesses depending on a variety offactors, such as the type of treatment being implemented or the natureand size of a tissue site. For example, the size and shape of the tissueinterface 108 may be adapted to the contours of deep and irregularshaped tissue sites.

In some embodiments, the tissue interface 108 may be a manifold. A“manifold” in this context generally includes any substance or structureproviding a plurality of pathways adapted to collect or distribute fluidacross a tissue site under negative pressure. For example, a manifoldmay be adapted to receive negative pressure from a source and distributethe negative pressure through multiple apertures across a tissue site,which may have the effect of collecting fluid from across a tissue siteand drawing the fluid toward the source. In some embodiments, the fluidpath may be reversed or a secondary fluid path may be provided tofacilitate delivering fluid across a tissue site.

In some illustrative embodiments, the pathways of a manifold may bechannels that are interconnected to improve distribution or collectionof fluids across a tissue site. For example, cellular foam, open-cellfoam, reticulated foam, porous tissue collections, and other porousmaterial such as gauze or felted mat generally include pores, edges,and/or walls adapted to form interconnected fluid pathways. Liquids,gels, and other foams may also include or be cured to include aperturesand flow channels. In some illustrative embodiments, a manifold may be aporous foam material having interconnected cells or pores adapted touniformly (or quasi-uniformly) distribute negative pressure to a tissuesite. The foam material may be either hydrophobic or hydrophilic. In onenon-limiting example, a manifold may be an open-cell, reticulatedpolyurethane foam such as ^(GranuFoam)® dressing available from KineticConcepts, Inc. of San Antonio, Texas.

In an example in which the tissue interface 108 may be made from ahydrophilic material, the tissue interface 108 may also wick fluid awayfrom a tissue site, while continuing to distribute negative pressure tothe tissue site. The wicking properties of the tissue interface 108 maydraw fluid away from a tissue site by capillary flow or other wickingmechanisms. An example of a hydrophilic foam is a polyvinyl alcohol,open-cell foam such as V.A.C. WhiteFoam® dressing available from KineticConcepts, Inc. of San Antonio, Tex. Other hydrophilic foams may includethose made from polyether. Other foams that may exhibit hydrophiliccharacteristics include hydrophobic foams that have been treated orcoated to provide hydrophilicity.

The tissue interface 108 may further promote granulation at a tissuesite when pressure within the sealed therapeutic environment is reduced.For example, any or all of the surfaces of the tissue interface 108 mayhave an uneven, coarse, or jagged profile that can induce microstrainsand stresses at a tissue site if negative pressure is applied throughthe tissue interface 108.

In some embodiments, the tissue interface 108 may be constructed frombioresorbable materials. Suitable bioresorbable materials may include,without limitation, a polymeric blend of polylactic acid (PLA) andpolyglycolic acid (PGA). The polymeric blend may also include withoutlimitation polycarbonates, polyfumarates, and capralactones. The tissueinterface 108 may further serve as a scaffold for new cell-growth, or ascaffold material may be used in conjunction with the tissue interface108 to promote cell-growth. A scaffold is generally a substance orstructure used to enhance or promote the growth of cells or formation oftissue, such as a three-dimensional porous structure that provides atemplate for cell growth. Illustrative examples of scaffold materialsinclude calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites,carbonates, or processed allograft materials. In some embodiments, thetissue interface 108 may be combined with hemostat material andanti-microbial materials to treat tissue sites that may have asignificant depth.

In some embodiments, the cover 103 may be a sealing layer and provide abacterial barrier and protection from physical trauma. The cover 103 mayalso be constructed from a material that can reduce evaporative lossesand provide a fluid seal between two components or two environments,such as between a therapeutic environment and a local externalenvironment. The cover 103 may be, for example, an elastomeric film ormembrane that can provide a seal adequate to maintain a negativepressure at a tissue site for a given negative-pressure source. In someexample embodiments, the cover 103 may be a polymer drape, such as apolyurethane film, that is permeable to water vapor but impermeable toliquid. Such drapes typically have a thickness in the range of 25-50microns. For permeable materials, the permeability generally should below enough that a desired negative pressure may be maintained.

An attachment device may be used to attach the cover 103 to anattachment surface, such as undamaged epidermis, a gasket, or anothercover. The attachment device may take many forms. For example, anattachment device may be a medically-acceptable, pressure-sensitiveadhesive that extends about a periphery, a portion, or an entire sealingmember. In some embodiments, for example, some or all of the cover 103may be coated with an acrylic adhesive having a coating weight between25-65 g.s.m. Thicker adhesives, or combinations of adhesives, may beapplied in some embodiments, to improve the seal and reduce leaks. Otherexample embodiments of an attachment device may include a double-sidedtape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

Typically, patients having low-acuity tissue sites may be mobile and maynot require confinement to a care facility during the duration of thetreatment of the tissue site. Consequently, a dedicatednegative-pressure therapy system that requires a continuous supply ofelectrical current to provide negative-pressure therapy may not bepreferable for use as a treatment device. Ambulatory patients mayreceive beneficial negative-pressure therapy by using thenegative-pressure therapy system 100 described herein, which provides apeel-and-place dressing and negative-pressure source that allows thepatient to easily see the status of the negative-pressure therapy and toreapply negative-pressure therapy without the intervention of aclinician.

As shown in FIG. 1, the negative-pressure therapy system 100 can includethe tissue interface 108 and the dressing assembly 102 having the cover103, the pouch 105, and the negative-pressure source 104. The cover 103,the pouch 105, and the negative-pressure source 104 may be coupled toeach other and collectively placed over the tissue interface 108 andundamaged epidermis.

The pouch 105 may include an absorbent 124, a first outer layer, such asan upstream layer 126, and a second outer layer, such as a downstreamlayer 128. The upstream layer 126 and the downstream layer 128 mayenvelop or enclose the absorbent 124. The absorbent 124 may hold,stabilize, and/or solidify fluids collected from the tissue site. Theabsorbent 124 may be formed from materials referred to as “hydrogels,”“super-absorbents,” or “hydrocolloids.” If disposed within the dressingassembly 102, the absorbent 124 may be formed into fibers or spheres tomanifold negative pressure until the absorbent 124 becomes saturated.Spaces or voids between the fibers or spheres may allow a negativepressure that is supplied to the dressing assembly 102 to be transferredwithin and through the absorbent 124 to the tissue interface 108 and thetissue site. In some exemplary embodiments, the absorbent 124 may beTexsus FP2325 having a material density of about 800 grams per squaremeter (gsm). In other exemplary embodiments, the absorbent material maybe BASF 402C, Technical Absorbents 2317 available from TechnicalAbsorbents (www.techabsorbents.com), sodium polyacrylate superabsorbers, cellulosics (carboxy methyl cellulose and salts such assodium CMC), or alginates.

In some exemplary embodiments, the absorbent 124 may be formed ofgranular absorbent components that may be scatter coated onto a papersubstrate. Scatter coating involves spreading a granular absorbentpowder uniformly onto a textile substrate, such as paper. The substrate,having the granular absorbent powder disposed thereon, may be passedthrough an oven to cure the powder and cause the powder to adhere to thepaper substrate. The cured granular absorbent powder and substrate maybe passed through a calender machine to provide a smooth uniform surfaceto the absorbent material.

In some exemplary embodiments, the upstream layer 126 and the downstreamlayer 128 have perimeter dimensions that may be larger than theperimeter dimensions of the absorbent 124 so that, if the absorbent 124is positioned between the upstream layer 126 and the downstream layer128 and the center portions of the absorbent 124, the upstream layer126, and the downstream layer 128 are aligned, the upstream layer 126and the downstream layer 128 may extend beyond the perimeter of theabsorbent 124. In some exemplary embodiments, the upstream layer 126 andthe downstream layer 128 surround the absorbent 124. Peripheral portionsof the upstream layer 126 and the downstream layer 128 may be coupled sothat the upstream layer 126 and the downstream layer 128 enclose theabsorbent 124. The upstream layer 126 and the downstream layer 128 maybe coupled by high frequency welding, ultrasonic welding, heat welding,or impulse welding, for example. In other exemplary embodiments, theupstream layer 126 and the downstream layer 128 may be coupled bybonding or folding, for example.

The upstream layer 126 may be formed of non-woven material in someembodiments. For example, the upstream layer 126 may have a polyesterfibrous porous structure. The upstream layer 126 may be porous, butpreferably the upstream layer 126 is not perforated. The upstream layer126 may have a material density between about 80 gsm and about 150 gsm.In other exemplary embodiments, the material density may be lower orgreater depending on the particular application of the pouch 105. Insome embodiments, the upstream layer 126 may be a plurality of layers ofnon-woven material. The upstream layer 126 may be formed of LibeltexTDL2, for example. In other embodiments, the upstream layer 126 may alsobe formed of Libeltex TL4.

The downstream layer 128 may also be formed of a non-woven material insome embodiments. For example, the downstream layer 128 may have apolyester fibrous porous structure. The downstream layer 128 may beporous, but the downstream layer 128 preferably is not perforated. Thedownstream layer 128 may have a material density between about 80 gsmand about 150 gsm. In other exemplary embodiments, the material densitymay be lower or greater depending on the particular application of thepouch 105. The material density of the downstream layer 128 may begreater or less than the material density of the upstream layer 126. Insome embodiments, a thickness of the downstream layer 128 may be greaterthan a thickness of the upstream layer 126. In other embodiments, thethickness of the downstream layer 128 may be less than the thickness ofthe upstream layer 126. In some embodiments, the downstream layer 128may be a plurality of layers of non-woven material. The downstream layer128 may be formed of Libeltex TL4. In other exemplary embodiments, thedownstream layer 128 may be formed of Libeltex TDL2.

The upstream layer 126 and the downstream layer 128 may be manifoldinglayers configured to facilitate fluid movement through the pouch 105. Insome embodiments, the upstream layer 126 and the downstream layer 128may each have a hydrophobic side and a hydrophilic side. The hydrophobicside may also be referred to as a wicking side, wicking surface,distribution surface, distribution side, or fluid distribution surface.The hydrophobic side may be a smooth distribution surface configured tomove fluid along a grain of the upstream layer 126 and the downstreamlayer 128, distributing fluid throughout the upstream layer 126 and thedownstream layer 128. The hydrophilic side may be configured to acquirebodily fluid from the hydrophobic side to aid in bodily fluid movementinto the absorbent 124. The hydrophilic side may also be referred to asa fluid acquisition surface, fluid acquisition side, hydrophilicacquisition surface, or hydrophilic acquisition side. The hydrophilicside may be a fibrous surface and be configured to draw fluid into theupstream layer 126 and the downstream layer 128. In some embodiments,the hydrophilic side of the upstream layer 126 and the downstream layer128 may be positioned adjacent to the absorbent 124. In otherembodiments, the hydrophobic side of the upstream layer 126 and thedownstream layer 128 may be positioned adjacent to the absorbent 124. Instill other embodiments, the hydrophilic side of one of the upstreamlayer 126 or the downstream layer 128 may be positioned adjacent to theabsorbent 124, and the hydrophobic side of the other of the upstreamlayer 126 or the downstream layer 128 may be positioned adjacent to theabsorbent 124.

In some embodiments, the cover 103 may include or may be a hybrid drapehaving a barrier layer 110, a bonding adhesive layer 112, and a sealingadhesive layer 114. The barrier layer 110 may be formed from a range ofmedically approved films ranging in thickness from about 15 microns (μm)to about 50 microns (μm). The barrier layer 110 may comprise a suitablematerial or materials, such as the following: hydrophilic polyurethane(PU), cellulosics, hydrophilic polyamides, polyvinyl alcohol, polyvinylpyrrolidone, hydrophilic acrylics, hydrophilic silicone elastomers, andcopolymers of these. In some embodiments, the barrier layer 110 may beformed from a breathable cast matt polyurethane film sold by ExpopackAdvanced Coatings of Wrexham, United Kingdom, under the name INSPIRE2301.

The barrier layer 110 may have a high moisture vapor transmission rate(MVTR). The MVTR of the barrier layer 110 allows vapor to egress andinhibits liquids from exiting. In some embodiments, the MVTR of thebarrier layer 110 may be greater than or equal to 300 g/m²/24 hours. Inother embodiments, the MVTR of the barrier layer 110 may be greater thanor equal to 1000 g/m²/24 hours. The illustrative INSPIRE 2301 film mayhave an MVTR (inverted cup technique) of 14400 g/m²/24 hours and may beapproximately 30 microns thick. In other embodiments, a drape having alow MVTR or that allows no vapor transfer might be used. The barrierlayer 110 can also function as a barrier to liquids and microorganisms.

In some embodiments, the barrier layer 110 may be adapted to form abulge on a first side of the barrier layer and a cavity 111 on anopposite side of the barrier layer from the bulge. For example, thebarrier layer 110 may be placed on a mold and stretched to plasticallydeform a portion of the barrier layer 110, forming the cavity 111. Aperiphery of the barrier layer 110 that is not stretched by theformation of the cavity 111 may form a flange surrounding the cavity111. In some embodiments, the cavity 111 may be positioned so that aportion of the flange may be larger on a first side of the cavity 111than on a second side of the cavity 111. The disparity in sizes of theflange may form a foundational flange 130 and a sealing flange 131. Insome embodiments, the pouch 105 may be disposed in the cavity 111. Thecavity 111 may also be a portion of the barrier layer 110 that is freeof adhesive. For example, during manufacturing, a portion of the barrierlayer 110 may be left without the bonding adhesive layer 112; the areaof the barrier layer 110 without the bonding adhesive layer 112 may beequal to a surface area of the pouch 105 to be covered by the barrierlayer 110.

The foundational flange 130 may extend away from the cavity 111. In someembodiments, the foundational flange 130 may have a length and a widthsufficient to permit other objects to be coupled to the dressingassembly 102. For example, the foundational flange 130 may support thenegative-pressure source 104, as illustrated in FIG. 1.

The bonding adhesive layer 112 may be coupled to the barrier layer 110on a side of the barrier layer 110 having an opening of the cavity 111.In some embodiments, the bonding adhesive layer 112 may include anaperture 116. The aperture 116 may be coextensive with the opening ofthe cavity 111. For example, the bonding adhesive layer 112 may coverthe barrier layer 110 at the foundational flange 130 and the sealingflange 131, leaving the portion of the barrier layer 110 forming thecavity 111 free of the bonding adhesive layer 112.

The bonding adhesive layer 112 may comprise an acrylic adhesive, rubberadhesive, high-tack silicone adhesive, polyurethane, or other substance.In an illustrative example, the bonding adhesive layer 112 comprises anacrylic adhesive with coating weight of 15 grams/m² (gsm) to 70 grams/m²(gsm). The bonding adhesive layer 112 may be a continuous layer ofmaterial or may be a layer with apertures (not shown). The apertures maybe formed after application of the bonding adhesive layer 112 or may beformed by coating the bonding adhesive layer 112 in patterns on acarrier layer. In some embodiments, the bond strength of the bondingadhesive may have a peel adhesion or resistance to being peeled from astainless steel material between about 6 N/25 mm to about 10 N/25 mm onstainless steel substrate at 23° C. at 50% relative humidity based onthe American Society for Testing and Materials (“ASTM”) standard ASTMD3330. The bonding adhesive layer 112 may be about 30 microns to about60 microns in thickness.

The sealing adhesive layer 114 may be coupled to the bonding adhesivelayer 112 and the pouch 105. For example, the sealing adhesive layer 114may cover the sealing flange 131, the pouch 105, and the foundationalflange 130. The sealing adhesive layer 114 may be formed with theplurality of apertures 118. The apertures 118 may be numerous shapes,for example, circles, squares, stars, ovals, polygons, slits, complexcurves, rectilinear shapes, triangles, or other shapes. Each aperture118 of the plurality of apertures 118 may have an effective diameter,which is the diameter of a circular area having the same surface area asthe aperture 118. The average effective diameter of each aperture 118may typically be in the range of about 6 mm to about 50 mm. Theplurality of apertures 118 may have a uniform pattern or may be randomlydistributed in the sealing adhesive layer 114. Generally, the apertures118 may be disposed across a length and width of the sealing adhesivelayer 114.

The sealing adhesive layer 114 may comprise a silicone gel (or softsilicone), hydrocolloid, hydrogel, polyurethane gel, polyolefin gel,hydrogenated styrenic copolymer gels, or foamed gels with compositionsas listed, or soft closed cell foams (polyurethanes, polyolefins) coatedwith an adhesive (e.g., 30 gsm-70 gsm acrylic), polyurethane,polyolefin, or hydrogenated styrenic copolymers. The sealing adhesivelayer 114 may have a thickness in the range of about 100 microns (μm) toabout 1000 microns (μm). In some embodiments, the sealing adhesive layer114 may have stiffness between about 5 Shore OO and about 80 Shore OO.The sealing adhesive layer 114 may be hydrophobic or hydrophilic. Thesealing adhesive of the sealing adhesive layer 114 may be an adhesivehaving a low to medium tackiness, for example, a silicone polymer,polyurethane, or an additional acrylic adhesive. In some embodiments,the bond strength of the sealing adhesive may have a peel adhesion orresistance to being peeled from a stainless steel material between about0.5 N/25 mm to about 1.5 N/25 mm on stainless steel substrate at 23° C.at 50% relative humidity based on ASTM D3330. The sealing adhesive mayhave a tackiness such that the sealing adhesive may achieve the bondstrength above after a contact time of less than about 60 seconds.Tackiness may be considered a bond strength of an adhesive after a verylow contact time between the adhesive and a substrate. In someembodiments, the sealing adhesive layer 114 may have a tackiness thatmay be about 30% to about 50% of the tackiness of the bonding adhesiveof the bonding adhesive layer 112.

In the assembled state, the bonding adhesive layer 112 may be coupled tothe barrier layer 110. The sealing adhesive layer 114 may be coupled tothe bonding adhesive layer 112 at the sealing flange 131 and thefoundational flange 130 and to the pouch 105 at the cavity 111. In someembodiments, a scrim layer may be disposed in the sealing adhesive layer114. The scrim layer may provide additional mechanical support for thesealing adhesive layer 114. In some embodiments, the sealing adhesivelayer 114 may be treated on a portion and a side of the sealing adhesivelayer 114 adjacent to the pouch 105. The treated portion of the sealingadhesive layer 114 may reduce the tackiness of the sealing adhesivelayer 114 so that the sealing adhesive layer 114 may not readily adhereto the pouch 105. The initial tackiness of the sealing adhesive layer114 is preferably sufficient to initially couple the sealing adhesivelayer 114 to the epidermis by forming sealing couplings. Once in thedesired location, a force can be applied to the barrier layer 110 of thecover 103. For example, the user may rub the foundational flange 130 andthe sealing flange 131. This action can cause at least a portion of thebonding adhesive layer 112 to be forced into the plurality of apertures118 and into contact with the epidermis to form bonding couplings. Thebonding couplings provide secure, releasable mechanical fixation to theepidermis.

The average effective diameter of the plurality of apertures 118 for thesealing adhesive layer 114 may be varied as one control of the tackinessor adhesion strength of the cover 103. In this regard, there isinterplay between three main variables for each embodiment: thethickness of the sealing adhesive layer 114, the average effectivediameter of the plurality of apertures 118, and the tackiness of thebonding adhesive layer 112. The more bonding adhesive of the bondingadhesive layer 112 that extends through the apertures 118, the strongerthe bond of the bonding coupling. The thinner the sealing adhesive layer114, the more bonding adhesive of the bonding adhesive layer 112generally extends through the apertures 118 and the greater the bond ofthe bonding coupling. As an example of the interplay, if a very tackybonding adhesive layer 112 is used and the thickness of the sealingadhesive layer 114 is small, the average effective diameter of theplurality of apertures 118 may be relatively smaller than if the bondingadhesive layer 112 is less tacky and the sealing adhesive layer 114 isthicker. In some embodiments, the thickness of the sealing adhesivelayer 114 may be approximately 200 microns, the thickness of the bondingadhesive layer 112 may be approximately 30 microns with a tackiness of2000 g/25 cm wide strip, and the average effective diameter of eachaperture 118 may be approximately 6 mm.

As illustrated in FIG. 1, the negative-pressure source 104, which mayalso be referred to as a blister, may be coupled to the barrier layer110 of the foundational flange 130. The negative-pressure source 104 mayinclude a barrier layer and a biasing member, for example, a film layer132 and a foam block 134. In some embodiments, the film layer 132 mayform a source flange 136 and a source cavity 138. The source cavity 138may be a portion of the film layer 132 that is plastically deformed,such as by vacuum forming, thermoforming, micro-thermoforming, injectionmolding, or blow molding, for example. In some embodiments, the sourcecavity 138 may form walls of the negative-pressure source 104 that maybe resilient or flexible. The source flange 136 may be a portion of thefilm layer 132 adjacent to and surrounding an opening of the sourcecavity 138. In some embodiments, the foam block 134 may be disposed inthe source cavity 138. The source flange 136 may be coupled to thebarrier layer 110 of the foundational flange 130 to seal the foam block134 in the source cavity 138. In some embodiments, the source flange 136may be coupled to the barrier layer 110 by high frequency welding,ultrasonic welding, heat welding, or impulse welding, for example. Inother exemplary embodiments, the source flange 136 may be coupled to thebarrier layer 110 by bonding or folding, for example. In someembodiments, if the source flange 136 is coupled to the barrier layer110 of the foundational flange 130, the source cavity 138 may be fluidlyisolated from the ambient environment and the pouch 105.

The film layer 132 may be constructed from a material that can provide afluid seal between two components or two environments, such as betweenthe source cavity 138 and a local external environment, while allowingfor repeated elastic deformation of the film layer 132. The film layer132 may be, for example, an elastomeric film or membrane that canprovide a seal between the source cavity 138 and the ambientenvironment. In some example embodiments, the film layer 132 may be apolymer drape, such as a polyurethane film, that is permeable to watervapor but impermeable to liquid. Such drapes typically have a thicknessin the range of 25-50 microns. For permeable materials, the permeabilitygenerally should be low enough that a desired negative pressure may bemaintained. In an exemplary embodiment, the film layer 132 may be apolyurethane having a thickness between about 50 microns and about 250microns and preferably about 100 microns.

The foam block 134 may be a foam having a plurality of interconnectedflow channels. For example, cellular foam, open-cell foam, reticulatedfoam, porous tissue collections, and other porous material thatgenerally include pores, edges, and/or walls adapted to forminterconnected fluid pathways. Liquids, gels, and other foams may alsoinclude or be cured to include apertures and flow channels. In someillustrative embodiments, the foam block 134 may be a porous foammaterial having interconnected cells or pores adapted to uniformly (orquasi-uniformly) distribute fluid throughout the foam block 134. Thefoam material may be either hydrophobic or hydrophilic. In onenon-limiting example, the foam block 134 may be an open-cell,reticulated polyurethane foam such as GranuFoam® dressing available fromKinetic Concepts, Inc. of San Antonio, Texas. Another exemplaryembodiment of the foam block 134 may be Z48AA foam from FXI®. In someembodiments, the foam block 134 may include an indicator, such as acolor change dye. The indicator may change colors if contacted by aliquid. Consequently, if the foam block 134 changes colors, a user mayknow that the dressing assembly 102 is saturated.

Foam materials may have an elastic modulus, which may also be referredto as a foam modulus. Generally, the elastic modulus of a material maymeasure the resistance of the material to elastic deformation under aload. The elastic modulus of a material may be defined as the slope of astress-strain curve in the elastic deformation region of the curve. Theelastic deformation region of a stress-strain curve represents thatportion of the curve where a deformation of a material due to an appliedload is elastic, that is, not permanent. If the load is removed, thematerial may return to its pre-loaded state. Stiffer materials may havea higher elastic modulus, and more compliant materials may have a lowerelastic modulus. Generally, references to the elastic modulus of amaterial refers to a material under tension.

For some materials under compression, the elastic modulus can becompared between materials by comparing the compression force deflection(CFD) of the materials. Typically, CFD is determined experimentally bycompressing a sample of a material until the sample is reduced to about25% of its uncompressed size. The load applied to reach the 25%compression of the sample is then divided by the area of the sample overwhich the load is applied to arrive at the CFD. The CFD can also bemeasured by compressing a sample of a material to about 50% of thesample's uncompressed size. The CFD of a foam material can be a functionof compression level, polymer stiffness, cell structure, foam density,and cell pore size. In some embodiments, the foam block 134 may have aCFD that is greater than a CFD of the tissue interface 108. For example,the tissue interface 108 may have a 25% CFD of about 2 kPa. The tissueinterface 108 may compress to about 25% of its uncompressed size if aload of about 2 kPa is applied to the tissue interface 108. The foamblock 134 may have a CFD of about 4 kPA. The foam block 134 may compressto about 25% of its uncompressed size if a load of about 4 kPa isapplied to the foam block 134. Thus, the foam block 134 is moreresistant to deformation than the tissue interface 108.

Furthermore, CFD can represent the tendency of a foam to return to itsuncompressed state if a load is applied to compress the foam. Forexample, a foam having a CFD of about 4 kPa may exert about 4 kPa inreaction to 25% compression. The CFD of the foam block 134 may representthe ability of the foam block 134 to bias the film layer 132 toward anexpanded position. For example, if the foam block 134 is compressed to25% of its original size, the foam block 134 may exert a spring forcethat opposes the applied force over the area of the foam block 134 towhich the force is applied. The reactive force may be proportional tothe amount the foam block 134 is compressed.

The foam block 134 may have a free volume. The free volume of the foamblock 134 may be the volume of free space of the foam block 134, forexample, the volume of the plurality of channels of the foam block 134.In some embodiments, the free volume of the foam block 134 may begreater than the free volume of the sealed therapeutic environment. Forexample, the free volume of the foam block 134 may be greater than thefree volume of the pouch 105. If the tissue interface 108 is used withthe dressing assembly 102, the free volume of the foam block 134 may begreater than the combined free volume of the pouch 105 and the tissueinterface 108. For example, if the free volume of the pouch 105 is 10cm³ and the free volume of the tissue interface is 10 cm³, then the freevolume of the foam block 134 may be greater than about 20 cm³.

In some embodiments, the negative-pressure source 104 may be fluidlycoupled to the cavity 111 through a fluid inlet, such as the tube 140.The tube 140 may be representative of a fluid communication path betweenthe negative-pressure source 104 and the cavity 111. In otherembodiments, the tube 140 may be a sealed channel or other fluidpathway. The tube 140 may include a lumen 142 fluidly coupled to thesource cavity 138 and the pouch 105. In some embodiments, a valve, suchas a check valve 144, may be fluidly coupled to the lumen 142. Exemplarycheck valves 144 may include ball check valves, diaphragm check valves,swing check valves, stop-check valves, duckbill valves, or pneumaticnon-return valves. The check valve 144 may permit fluid communicationfrom the pouch 105 to the source cavity 138 and prevent fluidcommunication from the source cavity 138 to the pouch 105. For example,if a pressure in the pouch 105 is greater than a pressure in the sourcecavity 138, the check valve 144 may open, and if the pressure in thesource cavity 138 is greater than the pressure in the pouch 105, thecheck valve 144 may close.

In some embodiments, a filter may be disposed on an end of the tube 140.The filter may be a hydrophobic porous polymer filter having gelblocking properties. In some embodiments, the filter may be a non-gelblocking filter, such as a Gore MMT314 material having apolytetrafluoroethylene (PTFE) layer. The PTFE layer may face themanifolding structure to prevent fluid communication across the PTFElayer. In some embodiments, the filter may be on an end of the tube 140proximate to the dressing assembly 102. In other embodiments, the filtermay be on an end of the tube 140 proximate to the negative-pressuresource 104.

The source cavity 138 may also be fluidly coupled to the ambientenvironment through a fluid outlet, such as the tube 146. For example,the tube 146 having a lumen 148 may fluidly couple the source cavity 138to the ambient environment. The tube 146 may be representative of afluid communication path between the ambient environment and the sourcecavity 138. A valve, such as a check valve 150, may be fluidly coupledto the lumen 148 to control fluid communication through the lumen 148.Exemplary check valves 150 may include ball check valves, diaphragmcheck valves, swing check valves, stop-check valves, duckbill valves, orpneumatic non-return valves. In some embodiments, the check valve 150may permit fluid communication from the source cavity 138 to the ambientenvironment and prevent fluid communication from the ambient environmentto the source cavity 138. For example, if a pressure in the sourcecavity 138 is greater than a pressure in the ambient environment, thecheck valve 150 may open, and if the pressure in the ambient environmentis greater than the pressure in the source cavity 138, the check valve150 may close.

In some embodiments, a filter may be disposed on an end of the tube 146.The filter may be a hydrophobic porous polymer filter having gelblocking properties. In some embodiments, the filter may be a non-gelblocking filter, such as a Gore MMT314 material having apolytetrafluoroethylene (PTFE) layer. The PTFE layer may face themanifolding structure to prevent fluid communication across the PTFElayer. In some embodiments, the filter may be on an end of the tube 146proximate to the negative-pressure source 104. In other embodiments, thefilter may be on an end of the tube 140 proximate to the ambientenvironment.

In some embodiments, the tissue interface 108 may be disposed adjacentto a tissue site. If the tissue interface 108 is used, the thickness ofthe tissue interface 108 may preferably be less than about 10 mm. Thedressing assembly 102 may be disposed over the tissue interface 108 tocreate the sealed therapeutic environment. In some embodiments, thepouch 105 of the dressing assembly 102 may be positioned over the tissueinterface 108 and the negative-pressure source 104 may be positionedover undamaged tissue proximate the tissue interface 108. A force, suchas hand pressure, may be applied to the sealing flange 131 and thefoundational flange 130, urging the bonding adhesive of the bondingadhesive layer 112 through the apertures 118 of the sealing adhesivelayer 114 to form bonding couplings and securing the negative-pressuretherapy system 100 to the tissue site.

FIG. 2 is a perspective view illustrating additional details of thenegative-pressure source 104 in a first position, such as a collapsedposition, and FIG. 3 is a perspective view illustrating additionaldetails of the negative-pressure source 104 is a second position, suchas an expanded position. Once positioned, the negative-pressure source104 may be operated to generate a negative pressure in the pouch 105. Asshown in FIG. 2, a force 152, such as hand pressure, may be applied tothe film layer 132 over the foam block 134 to compress the foam block134 to the first position and decrease the volume of the source cavity138. If the foam block 134 and the source cavity 138 are fluidlyisolated from the ambient environment, compression of the foam block 134may increase the pressure in the source cavity 138. An increase ofpressure in the source cavity 138 may create a pressure differentialacross the check valve 144 that urges the check valve 144 to close.Similarly, an increase of pressure in the source cavity 138 may create apressure differential across the check valve 150 that urges the checkvalve 150 to open, allowing fluid from the source cavity 138 to flowthrough the tube 146 to the ambient environment. If the force 152 isremoved, the foam block 134 may expand, increasing the volume of thesource cavity 138 and decreasing the pressure in the source cavity 138.In response, the decrease in pressure in the source cavity 138 maycreate a pressure differential across the check valve 150 that urges thecheck valve 150 to close, preventing fluid from flowing from the ambientenvironment to the source cavity 138. The decrease in pressure in thesource cavity 138 may also create a pressure differential across thecheck valve 144 that urges the check valve 144 to open, permitting fluidflow from the pouch 105 to the source cavity 138. Fluid may flow fromthe pouch 105 to the source cavity 138 until the source cavity 138 andthe foam block 134 reach their respective uncompressed positions asshown in FIG. 3. In this manner, a portion of the total volume of fluidin the sealed therapeutic environment may be removed. In response to theremoval of a portion of the fluid, a smaller volume of fluid occupiesthe sealed therapeutic environment, decreasing the pressure in thesealed therapeutic environment. Each time the foam block 134 iscompressed and allowed to rebound, additional fluid may be removed fromthe sealed therapeutic environment, further decreasing the pressure.

Decreasing the pressure in the sealed therapeutic environment may createa pressure differential across the dressing assembly 102. If thepressure in the sealed therapeutic environment reaches the therapypressure for negative-pressure therapy, the CFD of the foam block 134may be insufficient to cause the foam block 134 to expand followingcompression of the foam block 134 from the second position of FIG. 3 tothe first position of FIG. 2. The therapy pressure may be the pressureat which negative-pressure therapy may be performed. In someembodiments, the therapy pressure provided by the foam block 134 may beabout 70 mm Hg of negative pressure. In other embodiments, the therapypressure provided by the foam block 134 may be between about 50 mm Hgand 150 mm Hg of negative pressure. If the foam block 134 remainscompressed as shown in FIG. 2, a patient or clinician may have anindication that the therapy pressure has been reached. The compressedfoam block 134 may also act as a pressure reservoir. Asnegative-pressure therapy is provided, there may be a natural leakage ordecline of negative pressure at the tissue site. As the negativepressure decreases in the sealed therapeutic environment, the pressuredifferential across the dressing assembly 102 may decrease and the foamblock 134 may gradually expand, reapplying negative pressure at thetissue site. In some embodiments, the negative-pressure source 104having the foam block 134 may maintain a therapeutic negative pressurefor about 8 hours or more.

FIG. 4 is a sectional view of an example embodiment of anegative-pressure therapy system 200 that can provide negative-pressuretherapy in accordance with this specification. The negative-pressuretherapy system 200 may be similar to and operate as described above withrespect to the negative-pressure therapy system 100. Similar elementshave similar reference numbers indexed to 200. As shown in FIG. 4, thenegative-pressure therapy system 200 can include a dressing assembly 202having a cover 203, a pouch 205, and a negative-pressure source 204. Thecover 203, the pouch 205, and the negative-pressure source 204 may becoupled to each other. In some embodiments, the negative-pressuretherapy system 200 can also include the tissue interface 108.

The pouch 205 may include an absorbent 224, a first outer layer, such asan upstream layer 226, and a second outer layer, such as a downstreamlayer 228. The upstream layer 226 and the downstream layer 228 mayenvelop or enclose the absorbent 224. The absorbent 224 may hold,stabilize, and/or solidify fluids that may be collected from the tissuesite. The absorbent 224 may be of the type referred to as “hydrogels,”“super-absorbents,” or “hydrocolloids.” If disposed within the dressingassembly 202, the absorbent 224 may be formed into fibers or spheres tomanifold negative pressure until the absorbent 224 becomes saturated.Spaces or voids between the fibers or spheres may allow a negativepressure that is supplied to the dressing assembly 202 to be transferredwithin and through the absorbent 224 to the tissue site. In someexemplary embodiments, the absorbent 224 may be Texsus FP2325 having amaterial density of about 800 grams per square meter (gsm). In otherexemplary embodiments, the absorbent material may be BASF 402C,Technical Absorbents 2317 available from Technical Absorbents(www.techabsorbents.com), sodium polyacrylate super absorbers,cellulosics (carboxy methyl cellulose and salts such as sodium CMC), oralginates.

In some exemplary embodiments, the absorbent 224 may be formed ofgranular absorbent components that may be scatter coated onto a papersubstrate. Scatter coating involves spreading a granular absorbentpowder uniformly onto a textile substrate, such as paper. The substrate,having the granular absorbent powder disposed thereon, may be passedthrough an oven to cure the powder and cause the powder to adhere to thepaper substrate. The cured granular absorbent powder and substrate maybe passed through a calender machine to provide a smooth uniform surfaceto the absorbent material.

In some exemplary embodiments, the upstream layer 226 and the downstreamlayer 228 have perimeter dimensions that may be larger than theperimeter dimensions of the absorbent 224 so that, if the absorbent 224is positioned between the upstream layer 226 and the downstream layer228 and the center portions of the absorbent 224, the upstream layer226, and the downstream layer 228 are aligned, the upstream layer 226and the downstream layer 228 may extend beyond the perimeter of theabsorbent 224. In some exemplary embodiments, the upstream layer 226 andthe downstream layer 228 surround the absorbent 224. Peripheral portionsof the upstream layer 226 and the downstream layer 228 may be coupled sothat the upstream layer 226 and the downstream layer 228 enclose theabsorbent 224. The upstream layer 226 and the downstream layer 228 maybe coupled by high frequency welding, ultrasonic welding, heat welding,or impulse welding, for example. In other exemplary embodiments, theupstream layer 226 and the downstream layer 228 may be coupled bybonding or folding, for example.

The upstream layer 226 may be formed of non-woven material in someembodiments. For example, the upstream layer 226 may have a polyesterfibrous porous structure. The upstream layer 226 may be porous, butpreferably the upstream layer 226 is not perforated. The upstream layer226 may have a material density between about 80 gsm and about 150 gsm.In other exemplary embodiments, the material density may be lower orgreater depending on the particular application of the pouch 205. Insome embodiments, the upstream layer 226 may a plurality of layers of,for example, non-woven material. The upstream layer 226 may be formed ofLibeltex TDL2, for example. In other embodiments, the upstream layer 226may also be formed of Libeltex TL4. The upstream layer 226 may have ahydrophilic side and a hydrophobic side.

The downstream layer 228 may also be formed of a non-woven material insome embodiments. For example, the downstream layer 228 may have apolyester fibrous porous structure. The downstream layer 228 may beporous, but the downstream layer 228 preferably is not perforated. Thedownstream layer 228 may have a material density between about 80 gsmand about 150 gsm. In other exemplary embodiments, the material densitymay be lower or greater depending on the particular application of thepouch 205. The material density of the downstream layer 228 may begreater or less than the material density of the upstream layer 226. Insome embodiments, a thickness of the downstream layer 228 may be greaterthan a thickness of the upstream layer 226. In other embodiments, thethickness of the downstream layer 228 may be less than the thickness ofthe upstream layer 226. In some embodiments, the downstream layer 228may a plurality of layers of, for example, non-woven material. Thedownstream layer 228 may be formed of Libeltex TL4. In other exemplaryembodiments, the downstream layer 228 may be formed of Libeltex TDL2.

The upstream layer 226 and the downstream layer 228 may be manifoldinglayers configured to facilitate fluid movement through the pouch 205. Insome embodiments, the upstream layer 226 and the downstream layer 228may each have a hydrophobic side and a hydrophilic side. The hydrophobicside may also be referred to as a wicking side, wicking surface,distribution surface, distribution side, or fluid distribution surface.The hydrophobic side may be a smooth distribution surface configured tomove fluid along a grain of the upstream layer 226 and the downstreamlayer 228, distributing fluid throughout the upstream layer 226 and thedownstream layer 228. The hydrophilic side may be configured to acquirebodily fluid from the hydrophobic side to aid in bodily fluid movementinto the absorbent 224. The hydrophilic side may also be referred to asa fluid acquisition surface, fluid acquisition side, hydrophilicacquisition surface, or hydrophilic acquisition side. The hydrophilicside may be a fibrous surface and be configured to draw fluid into theupstream layer 226 and the downstream layer 228. In some embodiments,the hydrophilic side of the upstream layer 226 and the downstream layer228 may be positioned adjacent to the absorbent 224. In otherembodiments, the hydrophobic side of the upstream layer 226 and thedownstream layer 228 may be positioned adjacent to the absorbent 224. Instill other embodiments, the hydrophilic side of one of the upstreamlayer 226 or the downstream layer 228 may be positioned adjacent to theabsorbent 224, and the hydrophobic side of the other of the upstreamlayer 226 or the downstream layer 228 may be positioned adjacent to theabsorbent 224.

In some embodiments, the cover 203 may include a barrier layer 210 andan adhesive layer 213 having a bonding adhesive 212 and a sealingadhesive 214. The barrier layer 210 may be formed from a range ofmedically approved films ranging in thickness from about 15 microns (μm)to about 50 microns (μm). The barrier layer 210 may comprise a suitablematerial or materials, such as the following: hydrophilic polyurethane(PU), cellulosics, hydrophilic polyamides, polyvinyl alcohol, polyvinylpyrrolidone, hydrophilic acrylics, hydrophilic silicone elastomers, andcopolymers of these. In some embodiments, the barrier layer 210 may beformed from a breathable cast matt polyurethane film sold by ExpopackAdvanced Coatings of Wrexham, United Kingdom, under the name INSPIRE2301.

The barrier layer 210 may have a high moisture vapor transmission rate(MVTR). The MVTR of the barrier layer 210 allows vapor to egress andinhibits liquids from exiting. In some embodiments, the MVTR of thebarrier layer 210 may be greater than or equal to 300 g/m²/24 hours. Inother embodiments, the MVTR of the barrier layer 210 may be greater thanor equal to 1000 g/m²/24 hours. The illustrative INSPIRE 2301 film mayhave an MVTR (inverted cup technique) of 14400 g/m²/24 hours and may beapproximately 30 microns thick. In other embodiments, a drape having alow MVTR or that allows no vapor transfer might be used. The barrierlayer 210 can also function as a barrier to liquids and microorganisms.

In some embodiments, the barrier layer 210 may be adapted to form acavity 211. For example, the barrier layer 210 may be placed on a moldand stretched to plastically deform a portion of the barrier layer 210,forming the cavity 211. A periphery of the barrier layer 210 that is notstretched by the formation of the cavity 211 may form a flangesurrounding the cavity 211. In some embodiments, the cavity 211 may bepositioned so that a portion of the flange may be larger on a first sideof the cavity 211 than on a second side of the cavity 211. The disparityin sizes of the flange may form a foundational flange 230 and a sealingflange 231. In some embodiments, the pouch 205 may be disposed in thecavity 211. The cavity 211 may also be a portion of the barrier layer210 that is free of the adhesive layer 213. For example, duringmanufacturing, a portion of the barrier layer 210 may be left withoutthe adhesive layer 213; the area of the barrier layer 210 without theadhesive layer 213 may be equal to a surface area of the pouch 205 to becovered by the barrier layer 210.

The foundational flange 230 may extend away from the cavity 211. In someembodiments, the foundational flange 230 may have a length sufficient topermit other objects to be coupled to the dressing assembly 202. In someembodiments, the foundational flange 230 may support thenegative-pressure source 204, as illustrated in FIG. 4.

The adhesive layer 213 may be coupled to the barrier layer 210 on a sideof the barrier layer 210 having an opening of the cavity 211. In someembodiments, the adhesive layer 213 may include an aperture 216. Theaperture 216 may be coextensive with the opening of the cavity 211. Forexample, the adhesive layer 213 may cover the barrier layer 210 at thefoundational flange 230 and the sealing flange 231, leaving the portionof the barrier layer 210 forming the cavity 211 free of the adhesivelayer 213.

In some embodiments, the bonding adhesive 212 may be deposited onto thebarrier layer 210 in a pattern. For example, the bonding adhesive 212may be applied to the barrier layer 210 on a side of the barrier layer210 having the opening of the cavity 211 so that the bonding adhesive212 forms a checkerboard pattern. The barrier layer 210 may haveportions having the bonding adhesive 212 deposited thereon and portionsthat may be free of the bonding adhesive 212.

The sealing adhesive 214 may also be deposited onto the barrier layer210 in a pattern. For example, the sealing adhesive 214 may be appliedto the barrier layer 210 on the side of the barrier layer 210 having theopening of the cavity 211 so that the sealing adhesive 214 forms acheckerboard pattern. The barrier layer 210 may have portions having thesealing adhesive 214 deposited thereon and portions that may be free ofthe sealing adhesive 214.

The pattern of the bonding adhesive 212 and the pattern of the sealingadhesive 214 may be registered. Registration of the bonding adhesive 212and the sealing adhesive 214 generally refers to the alignment of thetwo adhesives relative to one another. In particular, registration ofthe bonding adhesive 212 and the sealing adhesive 214 may refer to thecoordination of adhesive placement on the barrier layer 210 to achieve adesired effect. For example, a certain percentage of overlap of oneadhesive over the other adhesive, minimal overlap of one adhesive overthe other adhesive so that the adhesives are offset from one another, orcomplete overlap of one adhesive over the other adhesive are alladhesive placements that may be considered registered. For example, thebonding adhesive 212 and the sealing adhesive 214 may be registered bybeing disposed on the barrier layer 210 so that the bonding adhesive 212and the sealing adhesive 214 each substantially couple to the barrierlayer 210. In addition, the bonding adhesive 212 and the sealingadhesive 214 of the example may be aligned relative to one another tohave minimal overlap of one adhesive over the other adhesive. In anotherexample, the sealing adhesive 214 may be offset from the bondingadhesive 212, with both adhesives being coupled to the barrier layer210. Registering the bonding adhesive 212 and the sealing adhesive 214provides for easier manufacturing and use of the cover 203. Registeringof the bonding adhesive 212 and the sealing adhesive 214 may alsoenhance desired properties of the cover 203.

The bonding adhesive 212 may comprise an acrylic adhesive, rubberadhesive, high-tack silicone adhesive, polyurethane, or other substance.In an illustrative example, the bonding adhesive 212 comprises anacrylic adhesive with coating weight of 15 grams/m² (gsm) to 70 grams/m²(gsm). In some embodiments, the bond strength of the bonding adhesivemay have a peel adhesion or resistance to being peeled from a stainlesssteel material between about 6 N/25 mm to about 10 N/25 mm on stainlesssteel substrate at 23° C. at 50% relative humidity based on the AmericanSociety for Testing and Materials (“ASTM”) standard ASTM D3330. Thebonding adhesive 212 may be about 30 microns to about 60 microns inthickness.

The sealing adhesive 214 may comprise a silicone gel (or soft silicone),hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenatedstyrenic copolymer gels, or foamed gels with compositions as listed, orsoft closed cell foams (polyurethanes, polyolefins) coated with anadhesive (e.g., 30 gsm-70 gsm acrylic), polyurethane, polyolefin, orhydrogenated styrenic copolymers. The sealing adhesive 214 may have athickness in the range of about 100 microns (μm) to about 1000 microns(μm). In some embodiments, the sealing adhesive 214 may have stiffnessbetween about 5 Shore OO and about 80 Shore OO. The sealing adhesive 214may be hydrophobic or hydrophilic. The sealing adhesive 214 may be anadhesive having a low to medium tackiness, for example, a siliconepolymer, polyurethane, or an additional acrylic adhesive. In someembodiments, the bond strength of the sealing adhesive may have a peeladhesion or resistance to being peeled from a stainless steel materialbetween about 0.5 N/25 mm to about 1.5 N/25 mm on stainless steelsubstrate at 23° C. at 50% relative humidity based on ASTM D3330. Thesealing adhesive 214 may have a tackiness such that the sealing adhesive214 may achieve the bond strength above after a contact time of lessthan 60 seconds. Tackiness may be considered a bond strength of anadhesive after a very low contact time between the adhesive and asubstrate. In some embodiments, the sealing adhesive 214 may have atackiness that may be about 30% to about 50% of the tackiness of thebonding adhesive of the bonding adhesive 212.

In the assembled state, the adhesive layer 213 may be coupled to thesealing flange 231 and the foundational flange 230. In some embodiments,the thickness of the bonding adhesive 212 may be less than the thicknessof the sealing adhesive 214 so that the adhesive layer 213 may have avarying thickness. If the adhesive layer 213 is placed proximate to orin contact with the epidermis of the patient, the sealing adhesive 214may be in contact with the epidermis to form sealing couplings. In someembodiments, the thickness of the bonding adhesive 212 may be less thanthe thickness of the sealing adhesive 214, forming a gap between thebonding adhesive 212 and the epidermis.

The initial tackiness of the sealing adhesive 214 is preferablysufficient to initially couple the sealing adhesive 214 to the epidermisby forming sealing couplings. Once in the desired location, a force canbe applied to the barrier layer 210 of the cover 203. For example, theuser may rub the foundational flange 230 and the sealing flange 231.This action can cause at least a portion of the bonding adhesive 212 tobe forced into the plurality of apertures 218 and into contact with theepidermis to form bonding couplings. The bonding couplings providesecure, releasable mechanical fixation to the epidermis.

As illustrated in FIG. 4, the negative-pressure source 204, which mayalso be referred to as a blister, may be coupled to the barrier layer210 of the foundational flange 230. The negative-pressure source 204 maybe an enclosure formed by a film layer 232 and having a foam block 234disposed therein. In some embodiments, the film layer 232 may form asource flange 236 and a source cavity 238. The source cavity 238 may bea portion of the film layer 232 this is plastically stretched, such asby vacuum forming, thermoforming, micro-thermoforming, injectionmolding, or blow molding, for example. In some embodiments, the sourcecavity 238 may form walls of the negative-pressure source 204 that maybe resilient or flexible. The source flange 236 may be a portion of thefilm layer 232 adjacent to and surrounding an opening of the sourcecavity 238. In some embodiments, the foam block 234 may be disposed inthe source cavity 238. The source flange 236 may be coupled to thebarrier layer 210 of the foundational flange 230 to seal the foam block234 in the source cavity 238. In some embodiments, the source flange 236may be coupled to the barrier layer 210 by high frequency welding,ultrasonic welding, heat welding, or impulse welding, for example. Inother exemplary embodiments, the source flange 236 may be coupled to thebarrier layer 210 by bonding or folding, for example. In someembodiments, if the source flange 236 is coupled to the barrier layer210 of the foundational flange 230, the source cavity 238 may be fluidlyisolated from the ambient environment and the pouch 205.

The film layer 232 may be constructed from a material that can provide afluid seal between two components or two environments, such as betweenthe source cavity 238 and a local external environment, while allowingfor repeated elastic deformation of the film layer 232. The film layer232 may be, for example, an elastomeric film or membrane that canprovide a seal between the source cavity 238 and the ambientenvironment. In some example embodiments, the film layer 232 may be apolymer drape, such as a polyurethane film, that is permeable to watervapor but impermeable to liquid. Such drapes typically have a thicknessin the range of 25-50 microns. For permeable materials, the permeabilitygenerally should be low enough that a desired negative pressure may bemaintained. In an exemplary embodiment, the film layer 232 may be apolyurethane having a thickness between about 50 microns and about 250microns and preferably about 100 microns.

The foam block 234 may be a foam having a plurality of interconnectedflow channels. For example, cellular foam, open-cell foam, reticulatedfoam, porous tissue collections, and other porous material thatgenerally include pores, edges, and/or walls adapted to forminterconnected fluid pathways. Liquids, gels, and other foams may alsoinclude or be cured to include apertures and flow channels. In someillustrative embodiments, the foam block 234 may be a porous foammaterial having interconnected cells or pores adapted to uniformly (orquasi-uniformly) distribute fluid throughout the foam block 234. Thefoam material may be either hydrophobic or hydrophilic. In onenon-limiting example, the foam block 234 may be an open-cell,reticulated polyurethane foam such as GranuFoam® dressing available fromKinetic Concepts, Inc. of San Antonio, Tex. Another exemplary embodimentof the foam block 234 may be Z48AA foam from FXI®.

Foam materials may have an elastic modulus, which may also be referredto as a foam modulus. Generally, the elastic modulus of a material maymeasure the resistance of the material to elastic deformation under aload. The elastic modulus of a material may be defined as the slope of astress-strain curve in the elastic deformation region of the curve. Theelastic deformation region of a stress-strain curve represents thatportion of the curve where a deformation of a material due to an appliedload is elastic, that is, not permanent. If the load is removed, thematerial may return to its pre-loaded state. Stiffer materials may havea higher elastic modulus, and more compliant materials may have a lowerelastic modulus. Generally, references to the elastic modulus of amaterial refers to a material under tension.

For some materials under compression, the elastic modulus can becompared between materials by comparing the compression force deflection(CFD) of the materials. Typically, CFD is determined experimentally bycompressing a sample of a material until the sample is reduced to about25% of its uncompressed size. The load applied to reach the 25%compression of the sample is then divided by the area of the sample overwhich the load is applied to arrive at the CFD. The CFD can also bemeasured by compressing a sample of a material to about 50% of thesample's uncompressed size. The CFD of a foam material can be a functionof compression level, polymer stiffness, cell structure, foam density,and cell pore size. The foam block 234 may have a CFD of about 4 kPA.The foam block 234 may compress to about 25% of its uncompressed size ifa load of about 4 kPa is applied to the foam block 234.

Furthermore, CFD can represent the tendency of a foam to return to itsuncompressed state if a load is applied to compress the foam. Forexample, a foam having a CFD of about 4 kPa may exert about 4 kPa inreaction to 25% compression. The CFD of the foam block 234 may representthe ability of the foam block 234 to bias the film layer 232 toward anexpanded position. For example, if the foam block 234 is compressed to25% of its original size, the foam block 234 may exert a spring forcethat opposes the applied force over the area of the foam block 234 towhich the force is applied. The reactive force may be proportional tothe amount the foam block 234 is compressed.

The foam block 234 may have a free volume. The free volume of the foamblock 234 may be the volume of free space of the foam block 234, forexample, the volume of the plurality of channels of the foam block 234.In some embodiments, the free volume of the foam block 234 may begreater than the free volume of the sealed therapeutic environment. Forexample, the free volume of the foam block 234 may be greater than thefree volume of the pouch 205. If the free volume of the pouch 205 isabout 10 cm³, then the free volume of the foam block 234 may be greaterthan about 10 cm³.

In some embodiments, the negative-pressure source 204 may be fluidlycoupled to the cavity 211 through a fluid inlet, such as a tube 240. Thetube 240 may be representative of a fluid communication path between thenegative-pressure source 204 and the cavity 211. In other embodiments,the tube 240 may be a sealed channel or other fluid pathway. The tube240 may include a lumen 242 fluidly coupled to the source cavity 238 andthe pouch 205. In some embodiments, a valve, such as a check valve 244,may be fluidly coupled to the lumen 242. Exemplary check valves 244 mayinclude ball check valves, diaphragm check valves, swing check valves,stop-check valves, duckbill valves, or pneumatic non-return valves. Thecheck valve 244 may permit fluid communication from the pouch 205 to thesource cavity 238 and prevent fluid communication from the source cavity238 to the pouch 205. For example, if a pressure in the pouch 205 isgreater than a pressure in the source cavity 238, the check valve 244may open, and if the pressure in the source cavity 238 is greater thanthe pressure in the pouch 205, the check valve 244 may close. In someembodiments, a filter may be disposed on an end of the tube 240. Thefilter may be a hydrophobic porous polymer filter having gel blockingproperties.

The source cavity 238 may also be fluidly coupled to the ambientenvironment through a fluid outlet, such as a tube 246. The tube 246 maybe representative of a fluid communication path between the ambientenvironment and the source cavity 238. For example, the tube 246 havinga lumen 248 may fluidly couple the source cavity 238 to the ambientenvironment. A valve, such as a check valve 250, may be fluidly coupledto the lumen 248 to control fluid communication through the lumen 248.Exemplary check valves 250 may include ball check valves, diaphragmcheck valves, swing check valves, stop-check valves, duckbill valves, orpneumatic non-return valves. In some embodiments, the check valve 250may permit fluid communication from the source cavity 238 to the ambientenvironment and prevent fluid communication from the ambient environmentto the source cavity 238. For example, if a pressure in the sourcecavity 238 is greater than a pressure in the ambient environment, thecheck valve 250 may open, and if the pressure in the ambient environmentis greater than the pressure in the source cavity 238, the check valve250 may close. In some embodiments, a filter may be disposed on an endof the tube 246. The filter may be a hydrophobic porous polymer filterhaving gel blocking properties.

FIG. 5 is a sectional view of an example embodiment of anegative-pressure therapy system 300 that can provide negative-pressuretherapy in accordance with this specification. The negative-pressuretherapy system 300 may be similar to and operate as described above withrespect to the negative-pressure therapy system 100. Similar elementshave similar reference numbers indexed to 300. As shown in FIG. 5, thenegative-pressure therapy system 300 can include a dressing assembly 302having a cover 303, a pouch 305, and a negative-pressure source 304. Thecover 303, the pouch 305, and the negative-pressure source 304 may becoupled to each other. In some embodiments, the negative-pressuretherapy system 300 can also include the tissue interface 108.

The pouch 305 may include an absorbent 324, a first outer layer, such asan upstream layer 326, and a second outer layer, such as a downstreamlayer 328. The upstream layer 326 and the downstream layer 328 mayenvelop or enclose the absorbent 324. The absorbent 324 may hold,stabilize, and/or solidify fluids that may be collected from the tissuesite. The absorbent 324 may be formed from materials referred to as“hydrogels,” “super-absorbents,” or “hydrocolloids.” If disposed withinthe dressing assembly 302, the absorbent 324 may be formed into fibersor spheres to manifold negative pressure until the absorbent 324 becomessaturated. Spaces or voids between the fibers or spheres may allow anegative pressure that is supplied to the dressing assembly 302 to betransferred within and through the absorbent 324 to the tissue site. Insome exemplary embodiments, the absorbent 324 may be Texsus FP2325having a material density of about 800 grams per square meter (gsm). Inother exemplary embodiments, the absorbent material may be BASF 402C,Technical Absorbents 2317 available from Technical Absorbents(www.techabsorbents.com), sodium polyacrylate super absorbers,cellulosics (carboxy methyl cellulose and salts such as sodium CMC), oralginates.

In some exemplary embodiments, the absorbent 324 may be formed ofgranular absorbent components that may be scatter coated onto a papersubstrate. Scatter coating involves spreading a granular absorbentpowder uniformly onto a textile substrate, such as paper. The substrate,having the granular absorbent powder disposed thereon, may be passedthrough an oven to cure the powder and cause the powder to adhere to thepaper substrate. The cured granular absorbent powder and substrate maybe passed through a calender machine to provide a smooth uniform surfaceto the absorbent material.

In some exemplary embodiments, the upstream layer 326 and the downstreamlayer 328 have perimeter dimensions that may be larger than theperimeter dimensions of the absorbent 324 so that, if the absorbent 324is positioned between the upstream layer 326 and the downstream layer328 and the center portions of the absorbent 324, the upstream layer326, and the downstream layer 328 are aligned, the upstream layer 326and the downstream layer 328 may extend beyond the perimeter of theabsorbent 324. In some exemplary embodiments, the upstream layer 326 andthe downstream layer 328 surround the absorbent 324. Peripheral portionsof the upstream layer 326 and the downstream layer 328 may be coupled sothat the upstream layer 326 and the downstream layer 328 enclose theabsorbent 324. The upstream layer 326 and the downstream layer 328 maybe coupled by high frequency welding, ultrasonic welding, heat welding,or impulse welding, for example. In other exemplary embodiments, theupstream layer 326 and the downstream layer 328 may be coupled bybonding or folding, for example.

The upstream layer 326 may be formed of non-woven material in someembodiments. For example, the upstream layer 326 may have a polyesterfibrous porous structure. The upstream layer 326 may be porous, butpreferably the upstream layer 326 is not perforated. The upstream layer326 may have a material density between about 80 gsm and about 150 gsm.In other exemplary embodiments, the material density may be lower orgreater depending on the particular application of the pouch 305. Insome embodiments, the upstream layer 326 may a plurality of layers of,for example, non-woven material. The upstream layer 326 may be formed ofLibeltex TDL2, for example. In other embodiments, the upstream layer 326may also be formed of Libeltex TL4. The upstream layer 326 may have ahydrophilic side and a hydrophobic side.

The downstream layer 328 may also be formed of a non-woven material insome embodiments. For example, the downstream layer 328 may have apolyester fibrous porous structure. The downstream layer 328 may beporous, but the downstream layer 328 preferably is not perforated. Thedownstream layer 328 may have a material density between about 80 gsmand about 150 gsm. In other exemplary embodiments, the material densitymay be lower or greater depending on the particular application of thepouch 305. The material density of the downstream layer 328 may begreater or less than the material density of the upstream layer 326. Insome embodiments, a thickness of the downstream layer 328 may be greaterthan a thickness of the upstream layer 326. In other embodiments, thethickness of the downstream layer 328 may be less than the thickness ofthe upstream layer 326. In some embodiments, the downstream layer 328may a plurality of layers of, for example, non-woven material. Thedownstream layer 328 may be formed of Libeltex TL4. In other exemplaryembodiments, the downstream layer 328 may be formed of Libeltex TDL2.

The upstream layer 326 and the downstream layer 328 may be manifoldinglayers configured to facilitate fluid movement through the pouch 305. Insome embodiments, the upstream layer 326 and the downstream layer 328may each have a hydrophobic side and a hydrophilic side. The hydrophobicside may also be referred to as a wicking side, wicking surface,distribution surface, distribution side, or fluid distribution surface.The hydrophobic side may be a smooth distribution surface configured tomove fluid along a grain of the upstream layer 326 and the downstreamlayer 328, distributing fluid throughout the upstream layer 326 and thedownstream layer 328. The hydrophilic side may be configured to acquirebodily fluid from the hydrophobic side to aid in bodily fluid movementinto the absorbent 324. The hydrophilic side may also be referred to asa fluid acquisition surface, fluid acquisition side, hydrophilicacquisition surface, or hydrophilic acquisition side. The hydrophilicside may be a fibrous surface and be configured to draw fluid into theupstream layer 326 and the downstream layer 328. In some embodiments,the hydrophilic side of the upstream layer 326 and the downstream layer328 may be positioned adjacent to the absorbent 324. In otherembodiments, the hydrophobic side of the upstream layer 326 and thedownstream layer 328 may be positioned adjacent to the absorbent 324. Instill other embodiments, the hydrophilic side of one of the upstreamlayer 326 or the downstream layer 328 may be positioned adjacent to theabsorbent 324, and the hydrophobic side of the other of the upstreamlayer 326 or the downstream layer 328 may be positioned adjacent to theabsorbent 324.

In some embodiments, the cover 303 may include or may be a hybrid drapethat includes a barrier layer 310, a bonding adhesive layer 312, and asealing adhesive layer 314. The barrier layer 310 may be formed from arange of medically approved films ranging in thickness from about 15microns (μm) to about 50 microns (μm). The barrier layer 310 maycomprise a suitable material or materials, such as the following:hydrophilic polyurethane (PU), cellulosics, hydrophilic polyamides,polyvinyl alcohol, polyvinyl pyrrolidone, hydrophilic acrylics,hydrophilic silicone elastomers, and copolymers of these. In someembodiments, the barrier layer 310 may be formed from a breathable castmatt polyurethane film sold by Expopack Advanced Coatings of Wrexham,United Kingdom, under the name INSPIRE 2301.

The barrier layer 310 may have a high moisture vapor transmission rate(MVTR). The MVTR of the barrier layer 310 allows vapor to egress andinhibits liquids from exiting. In some embodiments, the MVTR of thebarrier layer 310 may be greater than or equal to 300 g/m²/24 hours. Inother embodiments, the MVTR of the barrier layer 310 may be greater thanor equal to 1000 g/m²/24 hours. The illustrative INSPIRE 2301 film mayhave an MVTR (inverted cup technique) of 14400 g/m²/24 hours and may beapproximately 30 microns thick. In other embodiments, a drape having alow MVTR or that allows no vapor transfer might be used. The barrierlayer 310 can also function as a barrier to liquids and microorganisms.

In some embodiments, the barrier layer 310 may be adapted to form abulge on a first side of the barrier layer 310 and a cavity 311 on anopposite side of the barrier layer 310. For example, the barrier layer310 may be placed on a mold and stretched to plastically deform aportion of the barrier layer 310, forming the cavity 311. A periphery ofthe barrier layer 310 that is not stretched by the formation of thecavity 311 may form a flange surrounding the cavity 311. In someembodiments, the cavity 311 may be positioned so that a portion of theflange may be larger on a first side of the cavity 311 than on a secondside of the cavity 311. The disparity in sizes of the flange may form afoundational flange 330 and a sealing flange 331. In some embodiments,the pouch 305 may be disposed in the cavity 311. The cavity 311 may alsobe a portion of the barrier layer 310 that is free of the bondingadhesive layer 312. For example, during manufacturing, a portion of thebarrier layer 310 may be left without the bonding adhesive layer 312;the area of the barrier layer 310 without the bonding adhesive layer 312may be equal to a surface area of the pouch 305 to be covered by thebarrier layer 310.

The foundational flange 330 may extend away from the cavity 311. In someembodiments, the foundational flange 330 may have a length and a widthsufficient to permit other objects to be coupled to the dressingassembly 302. In some embodiments, the foundational flange 330 maysupport the negative-pressure source 304, as illustrated in FIG. 5.

The bonding adhesive layer 312 may be coupled to the barrier layer 310on a side of the barrier layer 310 having an opening of the cavity 311.In some embodiments, the bonding adhesive layer 312 may include anaperture 316. The aperture 316 may be coextensive with the opening ofthe cavity 311. For example, the bonding adhesive layer 312 may coverthe barrier layer 310 at the foundational flange 330 and the sealingflange 331, leaving the portion of the barrier layer 310 forming thecavity 311 free of bonding adhesive.

The bonding adhesive layer 312 may comprise an acrylic adhesive, rubberadhesive, high-tack silicone adhesive, polyurethane, or other substance.In an illustrative example, the bonding adhesive layer 312 comprises anacrylic adhesive with coating weight of 15 grams/m² (gsm) to 70 grams/m²(gsm). The bonding adhesive layer 312 may be a continuous layer ofmaterial or may be a layer with apertures (not shown). The apertures maybe formed after application of the bonding adhesive layer 312 or may beformed by coating the bonding adhesive layer 312 in patterns on acarrier layer. In some embodiments, the bond strength of the bondingadhesive may have a peel adhesion or resistance to being peeled from astainless steel material between about 6 N/25 mm to about 10 N/25 mm onstainless steel substrate at 23° C. at 50% relative humidity based onthe American Society for Testing and Materials (“ASTM”) standard ASTMD3330. The bonding adhesive layer 312 may be about 30 microns to about60 microns in thickness.

The sealing adhesive layer 314 may be coupled to the bonding adhesivelayer 312 and the pouch 305. For example, the sealing adhesive layer 314may cover the sealing flange 331, the pouch 305, and the foundationalflange 330. The sealing adhesive layer 314 may be formed with theplurality of apertures 318. The apertures 318 may be numerous shapes,for example, circles, squares, stars, ovals, polygons, slits, complexcurves, rectilinear shapes, triangles, or other shapes. Each aperture318 of the plurality of apertures 318 may have an effective diameter,which is the diameter of a circular area having the same surface area asthe aperture 318. The average effective diameter of each aperture 318may typically be in the range of about 6 mm to about 50 mm. Theplurality of apertures 318 may have a uniform pattern or may be randomlydistributed in the sealing adhesive layer 314. Generally, the apertures318 may be disposed across a length and width of the sealing adhesivelayer 314.

The sealing adhesive layer 314 may comprise a silicone gel (or softsilicone), hydrocolloid, hydrogel, polyurethane gel, polyolefin gel,hydrogenated styrenic copolymer gels, or foamed gels with compositionsas listed, or soft closed cell foams (polyurethanes, polyolefins) coatedwith an adhesive (e.g., 30 gsm-70 gsm acrylic), polyurethane,polyolefin, or hydrogenated styrenic copolymers. The sealing adhesivelayer 314 may have a thickness in the range of about 100 microns (μm) toabout 1000 microns (μm). In some embodiments, the sealing adhesive layer314 may have stiffness between about 5 Shore OO and about 80 Shore OO.The sealing adhesive layer 314 may be hydrophobic or hydrophilic. Thesealing adhesive of the sealing adhesive layer 314 may be an adhesivehaving a low to medium tackiness, for example, a silicone polymer,polyurethane, or an additional acrylic adhesive. In some embodiments,the bond strength of the sealing adhesive may have a peel adhesion orresistance to being peeled from a stainless steel material between about0.5 N/25 mm to about 1.5 N/25 mm on stainless steel substrate at 23° C.at 50% relative humidity based on ASTM D3330. The sealing adhesive ofthe sealing adhesive layer 314 may have a tackiness such that thesealing adhesive may achieve the bond strength above after a contacttime of less than 60 seconds. Tackiness may be considered a bondstrength of an adhesive after a very low contact time between theadhesive and a substrate. In some embodiments, the sealing adhesivelayer 314 may have a tackiness that may be about 30% to about 50% of thetackiness of the bonding adhesive of the bonding adhesive layer 312.

In the assembled state, the bonding adhesive layer 312 may be coupled tothe barrier layer 310. The sealing adhesive layer 314 may be coupled tothe bonding adhesive layer 312 at the sealing flange 331 and thefoundational flange 330 and to the pouch 305 at the cavity 311. In someembodiments, a scrim layer may be disposed in the sealing adhesive layer314. The scrim layer may provide additional mechanical support for thesealing adhesive layer 314. In some embodiments, the sealing adhesivelayer 314 may be treated on a portion and a side of the sealing adhesivelayer 314 adjacent to the pouch 305. The treated portion of the sealingadhesive layer 314 may reduce the tackiness of the sealing adhesivelayer 314 so that the sealing adhesive layer 314 may not readily adhereto the pouch 305. The initial tackiness of the sealing adhesive layer314 is preferably sufficient to initially couple the sealing adhesivelayer 314 to the epidermis by forming sealing couplings. Once in thedesired location, a force can be applied to the barrier layer 310 of thecover 303. For example, the user may rub the foundational flange 330 andthe sealing flange 331. This action can cause at least a portion of thebonding adhesive layer 312 to be forced into the plurality of apertures318 and into contact with the epidermis to form bonding couplings. Thebonding couplings provide secure, releasable mechanical fixation to theepidermis.

The average effective diameter of the plurality of apertures 318 for thesealing adhesive layer 314 may be varied as one control of the tackinessor adhesion strength of the cover 303. In this regard, there isinterplay between three main variables for each embodiment: thethickness of the sealing adhesive layer 314, the average effectivediameter of the plurality of apertures 318, and the tackiness of thebonding adhesive layer 312. The more bonding adhesive of the bondingadhesive layer 312 that extends through the apertures 318, the strongerthe bond of the bonding coupling. The thinner the sealing adhesive layer314, the more bonding adhesive of the bonding adhesive layer 312generally extends through the apertures 318 and the greater the bond ofthe bonding coupling. As an example of the interplay, if a very tackybonding adhesive layer 312 is used and the thickness of the sealingadhesive layer 314 is small, the average effective diameter of theplurality of apertures 318 may be relatively smaller than apertures 318in a thicker sealing adhesive layer 314 and less tacky bonding adhesivelayer 312. In some embodiments, the thickness of the sealing adhesivelayer 314 may be approximately 200 microns, the thickness of the bondingadhesive layer 312 is approximately 30 microns with a tackiness of 2000g/25 cm wide strip, and the average effective diameter of each aperture318 is approximately about 6 mm.

As illustrated in FIG. 5, the negative-pressure source 304, which mayalso be referred to as a blister, may be coupled to the barrier layer310 of the foundational flange 330. The negative-pressure source 304 mayinclude a barrier layer and a biasing member, for example, a film layer332, a first foam block 334, and a second foam block 335. In someembodiments, the film layer 332 may form a source flange 336 and asource cavity 338. The source cavity 338 may be a portion of the filmlayer 332 that is plastically deformed, such as by vacuum forming,thermoforming, micro-thermoforming, injection molding, or blow molding,for example. In some embodiments, the source cavity 338 may form wallsof the negative-pressure source 304 that may be resilient or flexible.The source flange 336 may be a portion of the film layer 332 adjacent toand surrounding an opening of the source cavity 338. In someembodiments, the first foam block 334 and the second foam block 335 maybe disposed in the source cavity 338. For example, the first foam block334 and the second foam block 335 may be stacked over one another andpositioned within the source cavity 338. The source flange 336 may becoupled to the barrier layer 310 of the foundational flange 330 to sealthe first foam block 334 and the second foam block 335 in the sourcecavity 338. In some embodiments, the source flange 336 may be coupled tothe barrier layer 310 by high frequency welding, ultrasonic welding,heat welding, or impulse welding, for example. In other exemplaryembodiments, the source flange 336 may be coupled to the barrier layer310 by bonding or folding, for example. In some embodiments, if thesource flange 336 is coupled to the barrier layer 310 of thefoundational flange 330, the source cavity 338 may be fluidly isolatedfrom the ambient environment and the pouch 305.

The film layer 332 may be constructed from a material that can provide afluid seal between two components or two environments, such as betweenthe source cavity 238 and a local external environment, while allowingfor repeated elastic deformation of the film layer 332. The film layer332 may be, for example, an elastomeric film or membrane that canprovide a seal between the source cavity 338 and the ambientenvironment. In some example embodiments, the film layer 332 may be apolymer drape, such as a polyurethane film, that is permeable to watervapor but impermeable to liquid. Such drapes typically have a thicknessin the range of 25-50 microns. For permeable materials, the permeabilitygenerally should be low enough that a desired negative pressure may bemaintained. In an exemplary embodiment, the film layer 332 may be apolyurethane having a thickness between about 50 microns and about 250microns and preferably about 100 microns.

The first foam block 334 and the second foam block 335 may have similardimensions. For example, if the first foam block 334 and the second foamblock 335 are cylindrical, the first foam block 334 and the second foamblock 335 may have similar diameters. The first foam block 334 and thesecond foam block 335 may be a foam having a plurality of interconnectedflow channels. For example, cellular foam, open-cell foam, reticulatedfoam, porous tissue collections, and other porous material thatgenerally include pores, edges, and/or walls adapted to forminterconnected fluid pathways. Liquids, gels, and other foams may alsoinclude or be cured to include apertures and flow channels. In someillustrative embodiments, the first foam block 334 and the second foamblock 335 may be a porous foam material having interconnected cells orpores adapted to uniformly (or quasi-uniformly) distribute fluidthroughout the first foam block 334 and the second foam block 335. Thefoam material may be either hydrophobic or hydrophilic. In onenon-limiting example, the first foam block 334 and the second foam block335 may be an open-cell, reticulated polyurethane foam such asGranuFoam® dressing available from Kinetic Concepts, Inc. of SanAntonio, Tex. Another exemplary embodiment of the first foam block 334and the second foam block 335 may be Z48AA foam from FXI.

Foam materials may have an elastic modulus, which may also be referredto as a foam modulus. Generally, the elastic modulus of a material maymeasure the resistance of the material to elastic deformation under aload. The elastic modulus of a material may be defined as the slope of astress-strain curve in the elastic deformation region of the curve. Theelastic deformation region of a stress-strain curve represents thatportion of the curve where the deformation of the material due to theapplied load is elastic, that is, not permanent. If the load is removed,the material may return to its pre-loaded state. Stiffer materials mayhave a higher elastic modulus, and more compliant materials may have alower elastic modulus. Generally, references to the elastic modulus of amaterial refers to a material under tension.

For foam materials under compression, the elastic modulus can comparedbetween materials by comparing the compression force deflection (CFD) ofthe materials. Typically, CFD is determined experimentally bycompressing a sample of a material until the sample is reduced to about25% of its uncompressed size. The load applied to reach the 25%compression of the sample is then divided by the area of the sample overwhich the load is applied to arrive at the CFD. The CFD can also bemeasured by compressing a sample of a material to about 50% of thesample's uncompressed size. The CFD of a foam material can be a functionof compression level, polymer stiffness, cell structure, foam density,and cell pore size. In some embodiments, the first foam block 334 andthe second foam block 335 may have a CFD that is greater than a CFD ofthe tissue interface 108. For example, the tissue interface 108 may havea 25% CFD of about 2 kPa. The tissue interface 108 may compress to about25% of its uncompressed size if a load of about 2 kPa is applied to thetissue interface 108. The first foam block 334 and the second foam block335 may have a CFD of about 4 kPA. The first foam block 334 and thesecond foam block 335 may compress to about 25% of its uncompressed sizeif a load of about 4 kPa is applied to the first foam block 334 and thesecond foam block 335. Thus, the first foam block 334 and the secondfoam block 335 is more resistant to deformation than the tissueinterface 108.

Furthermore, CFD can represent the tendency of a foam to return to itsuncompressed state if a load is applied to compress the foam. Forexample, a foam having a CFD of about 4 kPa may exert about 4 kPa inreaction to 25% compression. The CFD of the first foam block 334 and thesecond foam block 335 may represent the ability of the first foam block334 and the second foam block 335 to bias the film layer 332 toward anexpanded position. For example, if the first foam block 334 and thesecond foam block 335 is compressed to 25% of its original size, thefirst foam block 334 and the second foam block 335 may exert a springforce that opposes the applied force over the area of the first foamblock 334 and the second foam block 335 to which the force is applied.The reactive force may be proportional to the amount the first foamblock 334 and the second foam block 335 is compressed.

In some embodiments, the first foam block 334 and the second foam block335 may have different foam moduli. For example, the first foam block334 may have a first CFD so that the first foam block 334 may exert afirst force when in the compressed state that decreases as the firstfoam block 334 extends to the uncompressed state. Similarly, the secondfoam block 335 may have a second CFD so that the second foam block 335may exert a second force when in the compressed state that decreases asthe second foam block 335 extends to the uncompressed state. If thefirst foam block 334 and the second foam block 335 are stacked, thefirst force and the second force may be combined to reach a totaldesired spring force. In some embodiments, the CFD of the first foamblock 334 and the CFD of the second foam block 335 may be selected sothat the total desired spring force for the combined first foam block334 and the second foam block 335 is generally the same approaching theextended state as in the compressed state. For example, the first foamblock 334 and the second foam block 335 may be selected so that thecollective blocks exert the same upward force over the entire extensionof both the first foam block 334 and the second foam block 335.

The foam material of the first foam block 334 and the second foam block335 may be selected based on an expected volume of the pouch 305 and thetissue interface 108 (if used). The volume of the pouch 305 may define avolume of fluid to be withdrawn from the pouch 305 to achieve a therapypressure. For example, if the pouch 305 has a volume of about 50 cubiccentimeters, and no tissue interface 108 is used, removing about 10cubic centimeters of fluid from the pouch 305 may generate a negativepressure of about 125 mm Hg. To generate 125 mm Hg with a singlecompression of a single foam block having a volume of 10 cm³ the CFD ofthe single foam block may be around 17 kPa. Similarly, the moduli of thefirst foam block 334 and the second foam block 335 may be selected tohave a combined foam modulus of about 17 kPa. Having the first foamblock 334 and the second foam block 335 may allow for selection of twofoams having lower than 17 kPa moduli, which may each be more easilycompressed than a single foam having the 17 kPa modulus.

The first foam block 334 and the second foam block 335 may have a freevolume. The free volume of first foam block 334 and the second foamblock 335 may be the volume of free space of the first foam block 334and the second foam block 335, for example, the volume of the pluralityof channels of the first foam block 334 and the second foam block 335.In some embodiments, the free volume of the first foam block 334 and thesecond foam block 335 may be greater than the free volume of the pouch305. For example, if the free volume of the pouch 305 is 10 cm³, thenthe free volume of the first foam block 334 and the second foam block335 may be greater than about 20 cm³.

In some embodiments, the negative-pressure source 304 may be fluidlycoupled to the cavity 311 through a fluid inlet, such as a tube 340. Thetube 340 may be representative of a fluid communication path between thenegative-pressure source 304 and the cavity 311. In other embodiments,the tube 340 may be a sealed channel or other fluid pathway. The tube340 may include a lumen 342 fluidly coupled to the source cavity 338 andthe pouch 305. In some embodiments, a valve, such as a check valve 344,may be fluidly coupled to the lumen 342. Exemplary check valves 344 mayinclude ball check valves, diaphragm check valves, swing check valves,stop-check valves, duckbill valves, or pneumatic non-return valves. Thecheck valve 344 may permit fluid communication from the pouch 305 to thesource cavity 338 and prevent fluid communication from the source cavity338 to the pouch 305. For example, if a pressure in the pouch 305 isgreater than a pressure in the source cavity 338, the check valve 344may open, and if the pressure in the source cavity 338 is greater thanthe pressure in the pouch 305, the check valve 344 may close. In someembodiments, a filter may be disposed on an end of the tube 340. Thefilter may be a hydrophobic porous polymer filter having gel blockingproperties.

The source cavity 338 may also be fluidly coupled to the ambientenvironment through a fluid outlet, such as a tube 346. For example, thetube 346 having a lumen 348 may fluidly couple the source cavity 338 tothe ambient environment. The tube 346 may be representative of a fluidcommunication path between the ambient environment and the source cavity338. A valve, such as a check valve 350, may be fluidly coupled to thelumen 348 to control fluid communication through the lumen 348.Exemplary check valves 350 may include ball check valves, diaphragmcheck valves, swing check valves, stop-check valves, duckbill valves, orpneumatic non-return valves. In some embodiments, the check valve 350may permit fluid communication from the source cavity 338 to the ambientenvironment and prevent fluid communication from the ambient environmentto the source cavity 338. For example, if a pressure in the sourcecavity 338 is greater than a pressure in the ambient environment, thecheck valve 350 may open, and if the pressure in the ambient environmentis greater than the pressure in the source cavity 338, the check valve350 may close. In some embodiments, a filter may be disposed on an endof the tube 346. The filter may be a hydrophobic porous polymer filterhaving gel blocking properties.

The dressing assembly 302 may be disposed over the tissue site to formthe sealed therapeutic environment. In some embodiments, the pouch 305of the dressing assembly 302 may be positioned over the tissue site andthe negative-pressure source 304 may be positioned over undamaged tissueproximate the tissue interface 108. A force, such as hand pressure, maybe applied to the sealing flange 331 and the foundational flange 330,urging the bonding adhesive of the bonding adhesive layer 312 throughthe apertures 318 of the sealing adhesive layer 314 to form bondingcouplings and securing the negative-pressure therapy system 300 to thetissue site.

FIG. 6 is a perspective view illustrating additional details of thenegative-pressure source 304 in a first position, and FIG. 7 is aperspective view illustrating additional details of thenegative-pressure source 304 is a second position. Once positioned, thenegative-pressure source 304 may be operated to generate a negativepressure in the pouch 305. As shown in FIG. 6, a force 352, such as handpressure, may be applied to the film layer 332 over the first foam block334 to compress the first foam block 334 to the first position anddecrease the volume of the source cavity 338. If the first foam block334 and the source cavity 338 are fluidly isolated from the ambientenvironment, compression of the first foam block 334 may increase thepressure in the source cavity 338. An increase of pressure in the sourcecavity 338 may create a pressure differential across the check valve 344that urges the check valve 344 to close. Similarly, an increase ofpressure in the source cavity 338 may create a pressure differentialacross the check valve 350 that urges the check valve 350 to open,allowing fluid from the source cavity 338 to flow through the tube 346to the ambient environment. If the force 352 is removed, the first foamblock 334 may expand, increasing the volume of the source cavity 338 anddecreasing the pressure in the source cavity 338. In response, thedecrease in pressure in the source cavity 338 may create a pressuredifferential across the check valve 350 that urges the check valve 350to close, preventing fluid from flowing from the ambient environment tothe source cavity 338. The decrease in pressure in the source cavity 338may also create a pressure differential across the check valve 344 thaturges the check valve 344 to open, permitting fluid flow from the pouch305 to the source cavity 338. Fluid may flow from the pouch 305 to thesource cavity 338 until the source cavity 338 and the first foam block334 reach their respective uncompressed positions as shown in FIG. 7. Inthis manner, a portion of the total volume of fluid in the sealedtherapeutic environment may be removed. In response to the removal of aportion of the fluid, a smaller volume of fluid occupies the sealedtherapeutic environment, decreasing the pressure. Each time the firstfirst foam block 334 is compressed and allowed to rebound, additionalfluid may be removed from the sealed therapeutic environment, furtherdecreasing the pressure.

Decreasing the pressure in the source cavity 338, the cavity 311, andthe cavity between the pouch 305 and the tissue site may create apressure differential across the dressing assembly 302. If the pressurein the source cavity 338, the cavity 311, and the cavity between thepouch 305 and the tissue site reaches the therapy pressure fornegative-pressure therapy, the CFD of the first foam block 334 may beinsufficient to cause the first foam block 334 to expand followingcompression of the first foam block 334 from the second position of FIG.7 to the first position of FIG. 6. The therapy pressure may be thepressure at which negative-pressure therapy may be performed. In someembodiments, the therapy pressure provided by the first foam block 334may be about 70 mm Hg of negative pressure. In other embodiments, thetherapy pressure provided by the first foam block 334 may be betweenabout 50 mm Hg and 150 mm Hg of negative pressure. If the first foamblock 334 remains compressed as shown in FIG. 6, a patient or clinicianmay have an indication that the therapy pressure has been reached. Thecompressed first foam block 334 may also act as a pressure reservoir. Asnegative-pressure therapy is provided, there may be a natural leakage ordecline of negative pressure at the tissue site. As the negativepressure decreases in the cavity 311, the source cavity 338, and thecavity between the pouch 305 and the tissue site, the pressuredifferential across the dressing assembly 302 may decrease and the firstfoam block 334 may gradually expand, reapplying negative pressure at thetissue site. In some embodiments, the negative-pressure source 304having the first foam block 334 may maintain a therapeutic negativepressure for about 8 hours or more.

FIG. 8 is a sectional view of an example embodiment of anegative-pressure therapy system 400 that can provide negative-pressuretherapy in accordance with this specification. The negative-pressuretherapy system 400 may be similar to and operate as described above withrespect to the negative-pressure therapy system 100. Similar elementshave similar reference numbers indexed to 400. As shown in FIG. 8, thenegative-pressure therapy system 400 can include a dressing assembly 402having a cover 403, a pouch 405, and a negative-pressure source 404. Thecover 403, the pouch 405, and the negative-pressure source 404 may becoupled to each other. In some embodiments, the negative-pressuretherapy system 400 can also include the tissue interface 108.

The pouch 405 may include an absorbent 424, a first outer layer, such asan upstream layer 426, and a second outer layer, such as a downstreamlayer 428. The upstream layer 426 and the downstream layer 428 mayenvelop or enclose the absorbent 424. The absorbent 424 may hold,stabilize, and/or solidify fluids that may be collected from the tissuesite. The absorbent 424 may be formed from materials referred to as“hydrogels,” “super-absorbents,” or “hydrocolloids.” If disposed withinthe dressing assembly 402, the absorbent 424 may be formed into fibersor spheres to manifold negative pressure until the absorbent 424 becomessaturated. Spaces or voids between the fibers or spheres may allow anegative pressure that is supplied to the dressing assembly 402 to betransferred within and through the absorbent 424 to the tissue site. Insome exemplary embodiments, the absorbent 424 may be Texsus FP2325having a material density of about 800 grams per square meter (gsm). Inother exemplary embodiments, the absorbent material may be BASF 402C,Technical Absorbents 2317 available from Technical Absorbents(www.techabsorbents.com), sodium polyacrylate super absorbers,cellulosics (carboxy methyl cellulose and salts such as sodium CMC), oralginates.

In some exemplary embodiments, the absorbent 424 may be formed ofgranular absorbent components that may be scatter coated onto a papersubstrate. Scatter coating involves spreading a granular absorbentpowder uniformly onto a textile substrate, such as paper. The substrate,having the granular absorbent powder disposed thereon, may be passedthrough an oven to cure the powder and cause the powder to adhere to thepaper substrate. The cured granular absorbent powder and substrate maybe passed through a calender machine to provide a smooth uniform surfaceto the absorbent material.

In some exemplary embodiments, the upstream layer 426 and the downstreamlayer 428 have perimeter dimensions that may be larger than theperimeter dimensions of the absorbent 424 so that, if the absorbent 424is positioned between the upstream layer 426 and the downstream layer428 and the center portions of the absorbent 424, the upstream layer426, and the downstream layer 428 are aligned, the upstream layer 426and the downstream layer 428 may extend beyond the perimeter of theabsorbent 424. In some exemplary embodiments, the upstream layer 426 andthe downstream layer 428 may surround the absorbent 424. Peripheralportions of the upstream layer 426 and the downstream layer 428 may becoupled so that the upstream layer 426 and the downstream layer 428enclose the absorbent 424. The upstream layer 426 and the downstreamlayer 428 may be coupled by high frequency welding, ultrasonic welding,heat welding, or impulse welding, for example. In other exemplaryembodiments, the upstream layer 426 and the downstream layer 428 may becoupled by bonding or folding, for example.

The upstream layer 426 may be formed of non-woven material in someembodiments. For example, the upstream layer 426 may have a polyesterfibrous porous structure. The upstream layer 426 may be porous, butpreferably the upstream layer 426 is not perforated. The upstream layer426 may have a material density between about 80 gsm and about 150 gsm.In other exemplary embodiments, the material density may be lower orgreater depending on the particular application of the pouch 405. Theupstream layer 426 may be formed of Libeltex TDL2, for example. In otherembodiments, the upstream layer 426 may be formed of Libeltex TL4. Theupstream layer 426 may have a hydrophilic side and a hydrophobic side.

The downstream layer 428 may also be formed of a non-woven material insome embodiments. For example, the downstream layer 428 may have apolyester fibrous porous structure. The downstream layer 428 may beporous, but the downstream layer 428 preferably is not perforated. Thedownstream layer 428 may have a material density between about 80 gsmand about 150 gsm. In other exemplary embodiments, the material densitymay be lower or greater depending on the particular application of thepouch 405. The material density of the downstream layer 428 may begreater or less than the material density of the upstream layer 426. Insome embodiments, a thickness of the downstream layer 428 may be greaterthan a thickness of the upstream layer 426. In other embodiments, thethickness of the downstream layer 428 may be less than the thickness ofthe upstream layer 426. The downstream layer 428 may be formed ofLibeltex TL4. In other exemplary embodiments, the downstream layer 428may be formed of Libeltex TDL2.

The upstream layer 426 and the downstream layer 428 may be manifoldinglayers configured to facilitate fluid movement through the pouch 405. Insome embodiments, the upstream layer 426 and the downstream layer 428may each have a hydrophobic side and a hydrophilic side. The hydrophobicside may also be referred to as a wicking side, wicking surface,distribution surface, distribution side, or fluid distribution surface.The hydrophobic side may be a smooth distribution surface configured tomove fluid along a grain of the upstream layer 426 and the downstreamlayer 428, distributing fluid throughout the upstream layer 426 and thedownstream layer 428. The hydrophilic side may be configured to acquirebodily fluid from the hydrophobic side to aid in bodily fluid movementinto the absorbent 424. The hydrophilic side may also be referred to asa fluid acquisition surface, fluid acquisition side, hydrophilicacquisition surface, or hydrophilic acquisition side. The hydrophilicside may be a fibrous surface and be configured to draw fluid into theupstream layer 426 and the downstream layer 428. In some embodiments,the hydrophilic side of the upstream layer 426 and the downstream layer428 may be positioned adjacent to the absorbent 424. In otherembodiments, the hydrophobic side of the upstream layer 426 and thedownstream layer 428 may be positioned adjacent to the absorbent 424. Instill other embodiments, the hydrophilic side of one of the upstreamlayer 426 or the downstream layer 428 may be positioned adjacent to theabsorbent 424, and the hydrophobic side of the other of the upstreamlayer 426 or the downstream layer 428 may be positioned adjacent to theabsorbent 424.

In some embodiments, the cover 403 may include or may be a hybrid drapethat includes a barrier layer 410, a bonding adhesive layer 412, and asealing adhesive layer 414. The barrier layer 410 may be formed from arange of medically approved films ranging in thickness from about 15microns (μm) to about 50 microns (μm). The barrier layer 410 maycomprise a suitable material or materials, such as the following:hydrophilic polyurethane (PU), cellulosics, hydrophilic polyamides,polyvinyl alcohol, polyvinyl pyrrolidone, hydrophilic acrylics,hydrophilic silicone elastomers, and copolymers of these. In someembodiments, the barrier layer 410 may be formed from a breathable castmatt polyurethane film sold by Expopack Advanced Coatings of Wrexham,United Kingdom, under the name INSPIRE 2301.

The barrier layer 410 may have a high moisture vapor transmission rate(MVTR). The MVTR of the barrier layer 410 allows vapor to egress andinhibits liquids from exiting. In some embodiments, the MVTR of thebarrier layer 410 may be greater than or equal to 300 g/m²/24 hours. Inother embodiments, the MVTR of the barrier layer 410 may be greater thanor equal to 1000 g/m²/24 hours. The illustrative INSPIRE 2301 film mayhave an MVTR (inverted cup technique) of 14400 g/m²/24 hours and may beapproximately 30 microns thick. In other embodiments, a drape having alow MVTR or that allows no vapor transfer might be used. The barrierlayer 410 can also function as a barrier to liquids and microorganisms.

In some embodiments, the barrier layer 410 may be adapted to form abulge on a first side of the barrier layer 410 and a cavity 411 on anopposite side of the barrier layer 410. For example, the barrier layer410 may be placed on a mold and stretched to plastically deform aportion of the barrier layer 410, forming the cavity 411. A periphery ofthe barrier layer 410 that is not stretched by the formation of thecavity 411 may form a flange surrounding the cavity 411. In someembodiments, the cavity 411 may be positioned so that a portion of theflange may be larger on a first side of the cavity 411 than on a secondside of the cavity 411. The disparity in sizes of the flange may form afoundational flange 430 and a sealing flange 431. In some embodiments,the pouch 405 may be disposed in the cavity 411. The cavity 411 may alsobe a portion of the barrier layer 410 that is free of the bondingadhesive layer 412. For example, during manufacturing, a portion of thebarrier layer 410 may be left without the bonding adhesive layer 412;the area of the barrier layer 410 without the bonding adhesive layer 412may be equal to a surface area of the pouch 405 to be covered by thebarrier layer 410.

The foundational flange 430 may extend away from the cavity 411. In someembodiments, the foundational flange 430 may have a length and a widthsufficient to permit other objects to be coupled to the dressingassembly 402. In some embodiments, the foundational flange 430 maysupport the negative-pressure source 404, as illustrated in FIG. 8.

The bonding adhesive layer 412 may be coupled to the barrier layer 410on a side of the barrier layer 410 having an opening of the cavity 411.In some embodiments, the bonding adhesive layer 412 may include anaperture 416. The aperture 416 may be coextensive with the opening ofthe cavity 411. For example, the bonding adhesive layer 412 may coverthe barrier layer 410 at the foundational flange 430 and the sealingflange 431, leaving the portion of the barrier layer 410 forming thecavity 411 free of the bonding adhesive layer 412.

The bonding adhesive layer 412 may comprise an acrylic adhesive, rubberadhesive, high-tack silicone adhesive, polyurethane, or other substance.In an illustrative example, the bonding adhesive layer 412 comprises anacrylic adhesive with coating weight of 15 grams/m² (gsm) to 70 grams/m²(gsm). The bonding adhesive layer 412 may be a continuous layer ofmaterial or may be a layer with apertures (not shown). The apertures maybe formed after application of the bonding adhesive layer 412 or may beformed by coating the bonding adhesive layer 412 in patterns on acarrier layer. In some embodiments, the bond strength of the bondingadhesive may have a peel adhesion or resistance to being peeled from astainless steel material between about 6 N/25 mm to about 40 N/25 mm onstainless steel substrate at 23° C. at 50% relative humidity based onthe American Society for Testing and Materials (“ASTM”) standard ASTMD3330. The bonding adhesive layer 412 may be about 30 microns to about60 microns in thickness.

The sealing adhesive layer 414 may be coupled to the bonding adhesivelayer 412 and the pouch 405. For example, the sealing adhesive layer 414may cover the sealing flange 431, the pouch 405, and the foundationalflange 430. The sealing adhesive layer 414 may be formed with theplurality of apertures 418. The apertures 418 may be numerous shapes,for example, circles, squares, stars, ovals, polygons, slits, complexcurves, rectilinear shapes, triangles, or other shapes. Each aperture418 of the plurality of apertures 418 may have an effective diameter,which is the diameter of a circular area having the same surface area asthe aperture 418. The average effective diameter of each aperture 418may typically be in the range of about 6 mm to about 50 mm. Theplurality of apertures 418 may have a uniform pattern or may be randomlydistributed in the sealing adhesive layer 414. Generally, the apertures418 may be disposed across a length and width of the sealing adhesivelayer 414.

The sealing adhesive layer 414 may comprise a silicone gel (or softsilicone), hydrocolloid, hydrogel, polyurethane gel, polyolefin gel,hydrogenated styrenic copolymer gels, or foamed gels with compositionsas listed, or soft closed cell foams (polyurethanes, polyolefins) coatedwith an adhesive (e.g., 40 gsm-70 gsm acrylic), polyurethane,polyolefin, or hydrogenated styrenic copolymers. The sealing adhesivelayer 414 may have a thickness in the range of about 100 microns (μm) toabout 1000 microns (μm). In some embodiments, the sealing adhesive layer414 may have stiffness between about 5 Shore OO and about 80 Shore OO.The sealing adhesive layer 414 may be hydrophobic or hydrophilic. Thesealing adhesive of the sealing adhesive layer 414 may be an adhesivehaving a low to medium tackiness, for example, a silicone polymer,polyurethane, or an additional acrylic adhesive. In some embodiments,the bond strength of the sealing adhesive may have a peel adhesion orresistance to being peeled from a stainless steel material between about0.5 N/25 mm to about 4.5 N/25 mm on stainless steel substrate at 23° C.at 50% relative humidity based on ASTM D3330. The sealing adhesive mayhave a tackiness such that the sealing adhesive may achieve the bondstrength above after a contact time of less than 60 seconds. Tackinessmay be considered a bond strength of an adhesive after a very lowcontact time between the adhesive and a substrate. In some embodiments,the sealing adhesive layer 414 may have a tackiness that may be about40% to about 50% of the tackiness of the bonding adhesive of the bondingadhesive layer 412.

In the assembled state, the bonding adhesive layer 412 may be coupled tothe barrier layer 410. The sealing adhesive layer 414 may be coupled tothe bonding adhesive layer 412 at the sealing flange 431 and thefoundational flange 430 and to the pouch 405 at the cavity 411. In someembodiments, a scrim layer may be disposed in the sealing adhesive layer414. The scrim layer may provide additional mechanical support for thesealing adhesive layer 414. In some embodiments, the sealing adhesivelayer 414 may be treated on a portion and a side of the sealing adhesivelayer 414 adjacent to the pouch 405. The treated portion of the sealingadhesive layer 414 may reduce the tackiness of the sealing adhesivelayer 414 so that the sealing adhesive layer 414 may not readily adhereto the pouch 405. The initial tackiness of the sealing adhesive layer414 is preferably sufficient to initially couple the sealing adhesivelayer 414 to the epidermis by forming sealing couplings. Once in thedesired location, a force can be applied to the barrier layer 410 of thecover 403. For example, the user may rub the foundational flange 430 andthe sealing flange 431. This action can cause at least a portion of thebonding adhesive layer 412 to be forced into the plurality of apertures418 and into contact with the epidermis to form bonding couplings. Thebonding couplings provide secure, releasable mechanical fixation to theepidermis.

The average effective diameter of the plurality of apertures 418 for thesealing adhesive layer 414 may be varied as one control of the tackinessor adhesion strength of the cover 403. In this regard, there isinterplay between three main variables for each embodiment: thethickness of the sealing adhesive layer 414, the average effectivediameter of the plurality of apertures 418, and the tackiness of thebonding adhesive layer 412. The more bonding adhesive of the bondingadhesive layer 412 that extends through the apertures 418, the strongerthe bond of the bonding coupling. The thinner the sealing adhesive layer414, the more bonding adhesive of the bonding adhesive layer 412generally extends through the apertures 418 and the greater the bond ofthe bonding coupling. As an example of the interplay, if a very tackybonding adhesive layer 412 is used and the thickness of the sealingadhesive layer 414 is small, the average effective diameter of theplurality of apertures 418 may be relatively smaller than apertures 418in a thicker sealing adhesive layer 414 and a less tacky bondingadhesive layer 412. In some embodiments, the thickness of the sealingadhesive layer 414 may be approximately 200 microns, the thickness ofthe bonding adhesive layer 412 is approximately 30 microns with atackiness of 2000 g/25 cm wide strip, and the average effective diameterof each aperture 418 is approximately about 6 mm.

As illustrated in FIG. 8, the negative-pressure source 404, which mayalso be referred to as a blister, may be coupled to the barrier layer410 of the foundational flange 430. The negative-pressure source 404 mayinclude a barrier layer and a biasing member, for example, a film layer432, a first foam block 434, a second foam block 435, and a third foamblock 437. In some embodiments, the film layer 432 may form a sourceflange 436 and a source cavity 438. The source cavity 438 may be aportion of the film layer 432 that is plastically deformed, such as byvacuum forming, thermoforming, micro-thermoforming, injection molding,or blow molding, for example. In some embodiments, the source cavity 438may form walls of the negative-pressure source 404 that may be resilientor flexible. The source flange 436 may be a portion of the film layer432 adjacent to and surrounding an opening of the source cavity 438. Insome embodiments, the first foam block 434, the second foam block 435,and the third foam block 437 may be disposed in the source cavity 438.For example, the first foam block 434, the second foam block 435, andthe third foam block 437 may be stacked over one another and positionedwithin the source cavity 438. The source flange 436 may be coupled tothe barrier layer 410 of the foundational flange 430 to seal the firstfoam block 434, the second foam block 435, and the third foam block 437in the source cavity 438. In some embodiments, the source flange 436 maybe coupled to the barrier layer 410 by high frequency welding,ultrasonic welding, heat welding, or impulse welding, for example. Inother exemplary embodiments, the source flange 436 may be coupled to thebarrier layer 410 by bonding or folding, for example. In someembodiments, if the source flange 436 is coupled to the barrier layer410 of the foundational flange 430, the source cavity 438 may be fluidlyisolated from the ambient environment and the pouch 405.

The film layer 432 may be constructed from a material that can provide afluid seal between two components or two environments, such as betweenthe source cavity 438 and a local external environment, while allowingfor repeated elastic deformation of the film layer 432. The film layer432 may be, for example, an elastomeric film or membrane that canprovide a seal between the source cavity 438 and the ambientenvironment. In some example embodiments, the film layer 432 may be apolymer drape, such as a polyurethane film, that is permeable to watervapor but impermeable to liquid. Such drapes typically have a thicknessin the range of 25-50 microns. For permeable materials, the permeabilitygenerally should be low enough that a desired negative pressure may bemaintained. In an exemplary embodiment, the film layer 432 may be apolyurethane having a thickness between about 50 microns and about 250microns and preferably about 100 microns.

The first foam block 434, the second foam block 435, and the third foamblock 437 may have similar dimensions. For example, if the first foamblock 434, the second foam block 435, and the third foam block 437 arecylindrical, the first foam block 434, the second foam block 435, andthe third foam block 437 may have similar diameters. The first foamblock 434, the second foam block 435, and the third foam block 437 maybe a foam having a plurality of interconnected flow channels. Forexample, cellular foam, open-cell foam, reticulated foam, porous tissuecollections, and other porous material that generally include pores,edges, and/or walls adapted to form interconnected fluid pathways.Liquids, gels, and other foams may also include or be cured to includeapertures and flow channels. In some illustrative embodiments, the firstfoam block 434, the second foam block 435, and the third foam block 437may be a porous foam material having interconnected cells or poresadapted to uniformly (or quasi-uniformly) distribute fluid throughoutthe first foam block 434, the second foam block 435, and the third foamblock 437. The foam material may be either hydrophobic or hydrophilic.In one non-limiting example, the first foam block 434, the second foamblock 435, and the third foam block 437 may be an open-cell, reticulatedpolyurethane foam such as GranuFoam® dressing available from KineticConcepts, Inc. of San Antonio, Tex. Another exemplary embodiment of thefirst foam block 434, the second foam block 435, and the third foamblock 437 may be Z48AA foam from FXI.

Foam materials may have an elastic modulus, which may also be referredto as a foam modulus. Generally, the elastic modulus of a material maymeasure the resistance of the material to elastic deformation under aload. The elastic modulus of a material may be defined as the slope of astress-strain curve in the elastic deformation region of the curve. Theelastic deformation region of a stress-strain curve represents thatportion of the curve where the deformation of the material due to theapplied load is elastic, that is, not permanent. If the load is removed,the material may return to its pre-loaded state. Stiffer materials mayhave a higher elastic modulus, and more compliant materials may have alower elastic modulus. Generally, references to the elastic modulus of amaterial refers to a material under tension.

For foam materials under compression, the elastic modulus can comparedbetween materials by comparing the compression force deflection (CFD) ofthe materials. Typically, CFD is determined experimentally bycompressing a sample of a material until the sample is reduced to about25% of its uncompressed size. The load applied to reach the 25%compression of the sample is then divided by the area of the sample overwhich the load is applied to arrive at the CFD. The CFD can also bemeasured by compressing a sample of a material to about 50% of thesample's uncompressed size. The CFD of a foam material can be a functionof compression level, polymer stiffness, cell structure, foam density,and cell pore size. The first foam block 434, the second foam block 435,and the third foam block 437 may collectively have a CFD of about 4 kPA.The first foam block 434, the second foam block 435, and the third foamblock 437 may compress to about 25% of its uncompressed size if a loadof about 4 kPa is applied to the first foam block 434, the second foamblock 435, and the third foam block 437. Thus, the first foam block 434,the second foam block 435, and the third foam block 437 is moreresistant to deformation than the tissue interface 108.

Furthermore, CFD can represent the tendency of a foam to return to itsuncompressed state if a load is applied to compress the foam. Forexample, a foam having a CFD of about 4 kPa may exert about 4 kPa inreaction to 25% compression. The collective CFD of the first foam block434, the second foam block 435, and the third foam block 437 mayrepresent the ability of the first foam block 434, the second foam block435, and the third foam block 437 to bias the film layer 432 toward anexpanded position. For example, if the first foam block 434, the secondfoam block 435, and the third foam block 437 is compressed to 25% of itsoriginal size, the first foam block 434, the second foam block 435, andthe third foam block 437 may collectively exert a spring force thatopposes the applied force over the area of the first foam block 434, thesecond foam block 435, and the third foam block 437 to which the forceis applied. The reactive force may be proportional to the amount thefirst foam block 434, the second foam block 435, and the third foamblock 437 are compressed.

In some embodiments, the first foam block 434, the second foam block435, and the third foam block 437 may have different foam moduli. Forexample, the first foam block 434 may have a first CFD so that the firstfoam block 434 may exert a first force when in the compressed state thatdecreases as the first foam block 434 extends to the uncompressed state.Similarly, the second foam block 435 may have a second CFD so that thesecond foam block 435 may exert a second force when in the compressedstate that decreases as the second foam block 435 extends to theuncompressed state. The third foam block 437 may have a third CFD sothat the third foam block 437 may exert a third force when in thecompressed state that decreases as the third foam block 437 extends tothe uncompressed state. If the first foam block 434, the second foamblock 435, and the third foam block 437 are stacked, the first force,the second force, and the third may be combined to reach a total desiredspring force. In some embodiments, the CFD of the first foam block 434,the CFD of the second foam block 435, and the CFD of the third foamblock 437 may be selected so that the total desired spring force for thecombined first foam block 434, the second foam block 435, and the thirdfoam block 437 is generally the same approaching the extended state asin the compressed state. For example, the first foam block 434, thesecond foam block 435, and the third foam block 437 may be selected sothat the collective blocks exert the same upward force over the entireextension of both the first foam block 434, the second foam block 435,and the third foam block 437.

The foam material of the first foam block 434, the second foam block435, and the third foam block 437 may be selected based on an expectedvolume of the pouch 405 and the tissue interface 108 (if used). Thevolume of the pouch 405 may define a volume of fluid to be withdrawnfrom the pouch 405 to achieve a therapy pressure. For example, if thepouch 405 has a volume of about 50 cubic centimeters, and no tissueinterface 108 is used, removing about 10 cubic centimeters of fluid fromthe pouch 405 may generate a negative pressure of about 125 mm Hg. Togenerate 125 mm Hg with a single compression of a single foam blockhaving a volume of 10 cm³ the CFD of the single foam block may be around17 kPa. Similarly, the moduli of the first foam block 434, the secondfoam block 435, and the third foam block 437 may be selected to have acombined foam modulus of about 17 kPa. Having the first foam block 434,the second foam block 435, and the third foam block 437 may allow forselection of two foams having lower than 17 kPa moduli, which may eachbe more easily compressed than a single foam having the 17 kPa modulus.

The first foam block 434, the second foam block 435, and the third foamblock 437 may have a free volume. The free volume of first foam block434, the second foam block 435, and the third foam block 437 may be thevolume of free space of the first foam block 434, the second foam block435, and the third foam block 437, for example, the volume of theplurality of channels of the first foam block 434, the second foam block435, and the third foam block 437. In some embodiments, the free volumeof the first foam block 434, the second foam block 435, and the thirdfoam block 437 may be greater than the free volume of the pouch 405. Forexample, if the free volume of the pouch 405 is 10 cm³, then the freevolume of the first foam block 434, the second foam block 435, and thethird foam block 437 may be greater than about 20 cm³.

In some embodiments, the negative-pressure source 404 may be fluidlycoupled to the to the cavity 411 through a fluid inlet, such as a tube440. The tube 440 may be representative of a fluid communication pathbetween the negative-pressure source 404 and the cavity 411. In otherembodiments, the tube 440 may be a sealed channel or other fluidpathway. The tube 440 may include a lumen 442 fluidly coupled to thesource cavity 438 and the pouch 405. In some embodiments, a valve, suchas a check valve 444, may be fluidly coupled to the lumen 442. Exemplarycheck valves 444 may include ball check valves, diaphragm check valves,swing check valves, stop-check valves, duckbill valves, or pneumaticnon-return valves. The check valve 444 may permit fluid communicationfrom the pouch 405 to the source cavity 438 and prevent fluidcommunication from the source cavity 438 to the pouch 405. For example,if a pressure in the pouch 405 is greater than a pressure in the sourcecavity 438, the check valve 444 may open, and if the pressure in thesource cavity 438 is greater than the pressure in the pouch 405, thecheck valve 444 may close. In some embodiments, a filter may be disposedon an end of the tube 440. The filter may be a hydrophobic porouspolymer filter having gel blocking properties.

The source cavity 438 may also be fluidly coupled to the ambientenvironment through a fluid outlet, such as a tube 446. For example, thetube 446 having a lumen 448 may fluidly couple the source cavity 438 tothe ambient environment. The tube 446 may be representative of a fluidcommunication path between the ambient environment and the source cavity438. A valve, such as a check valve 450, may be fluidly coupled to thelumen 448 to control fluid communication through the lumen 448.Exemplary check valves 450 may include ball check valves, diaphragmcheck valves, swing check valves, stop-check valves, duckbill valves, orpneumatic non-return valves. In some embodiments, the check valve 450may permit fluid communication from the source cavity 438 to the ambientenvironment and prevent fluid communication from the ambient environmentto the source cavity 438. For example, if a pressure in the sourcecavity 438 is greater than a pressure in the ambient environment, thecheck valve 450 may open, and if the pressure in the ambient environmentis greater than the pressure in the source cavity 438, the check valve450 may close. In some embodiments, a filter may be disposed on an endof the tube 446. The filter may be a hydrophobic porous polymer filterhaving gel blocking properties.

The dressing assembly 402 may be disposed over the tissue site to formthe sealed therapeutic environment. In some embodiments, the pouch 405of the dressing assembly 402 may be positioned over the tissue site andthe negative-pressure source 404 may be positioned over undamaged tissueproximate the tissue site. A force, such as hand pressure, may beapplied to the sealing flange 431 and the foundational flange 430,urging the bonding adhesive of the bonding adhesive layer 412 throughthe apertures 418 of the sealing adhesive layer 414 to form bondingcouplings and securing the dressing assembly 402 to the tissue site.

FIG. 9 is a perspective view illustrating additional details of thenegative-pressure source 404. Once positioned, the negative-pressuresource 404 may be operated to generate a negative pressure in the pouch405. A force, such as hand pressure, may be applied to the film layer432 over the first foam block 434, the second foam block 435, and thethird foam block 437 to compress the first foam block 434, the secondfoam block 435, and the third foam block 437 to decrease the volume ofthe source cavity 438. If the first foam block 434, the second foamblock 435, and the third foam block 437 and the source cavity 438 arefluidly isolated from the ambient environment, compression of the firstfoam block 434, the second foam block 435, and the third foam block 437may increase the pressure in the source cavity 438. An increase ofpressure in the source cavity 438 may create a pressure differentialacross the check valve 444 that urges the check valve 444 to close.Similarly, an increase of pressure in the source cavity 438 may create apressure differential across the check valve 450 that urges the checkvalve 450 to open, allowing fluid from the source cavity 438 to flowthrough the tube 446 to the ambient environment. If the force isremoved, the first foam block 434, the second foam block 435, and thethird foam block 437 may expand, increasing the volume of the sourcecavity 438 and decreasing the pressure in the source cavity 438. Inresponse, the decrease in pressure in the source cavity 438 may create apressure differential across the check valve 450 that urges the checkvalve 450 to close, preventing fluid from flowing from the ambientenvironment to the source cavity 438. The decrease in pressure in thesource cavity 438 may also create a pressure differential across thecheck valve 444 that urges the check valve 444 to open, permitting fluidflow from the pouch 405 to the source cavity 438. Fluid may flow fromthe pouch 405 to the source cavity 438 until the source cavity 438 andthe first foam block 434, the second foam block 435, and the third foamblock 437 reach their respective uncompressed positions. In this manner,a portion of the total volume of fluid in the sealed therapeuticenvironment may be removed. In response to the removal of a portion ofthe fluid, a smaller volume of fluid occupies the sealed therapeuticenvironment, decreasing the pressure. Each time the first foam block434, the second foam block 435, and the third foam block 437 arecompressed and allowed to rebound, additional fluid may be removed fromthe sealed therapeutic environment, further decreasing the pressure.

Decreasing the pressure in the sealed therapeutic environment may createa pressure differential across the dressing assembly 402. If thepressure in the sealed therapeutic environment reaches the therapypressure for negative-pressure therapy, the CFD of the first foam block434, the second foam block 435, and the third foam block 437 may beinsufficient to cause the first foam block 434, the second foam block435, and the third foam block 437 to expand following compression of thefirst foam block 434, the second foam block 435, and the third foamblock 437. The therapy pressure may be the pressure at whichnegative-pressure therapy may be performed. In some embodiments, thetherapy pressure provided by the first foam block 434, the second foamblock 435, and the third foam block 437 may be about 70 mm Hg ofnegative pressure. In other embodiments, the therapy pressure providedby the first foam block 434, the second foam block 435, and the thirdfoam block 437 may be between about 50 mm Hg and 150 mm Hg of negativepressure. If the first foam block 434, the second foam block 435, andthe third foam block 437 remains compressed, a patient or clinician mayhave an indication that the therapy pressure has been reached. Thecompressed first foam block 434, the second foam block 435, and thethird foam block 437 may also act as a pressure reservoir. Asnegative-pressure therapy is provided, there may be a natural leakage ordecline of negative pressure at the tissue site. As the negativepressure decreases in the sealed therapeutic environment, the pressuredifferential across the dressing assembly 402 may decrease and the firstfoam block 434, the second foam block 435, and the third foam block 437may gradually expand, reapplying negative pressure at the tissue site.In some embodiments, the negative-pressure source 404 having the firstfoam block 434, the second foam block 435, and the third foam block 437may maintain a therapeutic negative pressure for about 8 hours or more.

In some embodiments, the fluid container and dressing assembly may beshaped to accommodate differently shaped tissue sites. For example, thepouch 105 and the dressing assembly 102 of FIG. 1-3 and the pouch 205and the dressing assembly 202 of FIG. 4 may have a square shape and alarge area to accommodate a tissue site having a large area. The pouch305 and the dressing assembly 302 of FIG. 5, FIG. 6, and FIG. 7 may havea curved shape to accommodate wounds having a significant curvature orthat may be located on or near an articulating joint. The pouch 405 andthe dressing assembly 402 of FIG. 8 and FIG. 9 may have a rectangularshape to accommodate a tissue site, such as a linear wound, that has ahigh length to width ratio.

In some embodiments, the foam block 134, 234, 334, 335, 434, 435, 437may be replaced with other types of elastic elements, such a polymercoil spring formed of polyurethane or acrylonitrile butadiene styrene(ABS). In some embodiments, the negative-pressure source 104, 204, 304,and 404 may comprise or may be a blow-molded bellows that is coupled tothe foundational flange 130, 230, 330, or 430.

While shown in a few illustrative embodiments, a person having ordinaryskill in the art will recognized that the systems, apparatuses, andmethods described herein are susceptible to various changes andmodifications. Moreover, descriptions of various alternatives usingterms such as “or” do not require mutual exclusivity unless clearlyrequired by the context, and the indefinite articles “a” or “an” do notlimit the subject to a single instance unless clearly required by thecontext.

The appended claims set forth novel and inventive aspects of the subjectmatter described above, but the claims may also encompass additionalsubject matter not specifically recited in detail. For example, certainfeatures, elements, or aspects may be omitted from the claims if notnecessary to distinguish the novel and inventive features from what isalready known to a person having ordinary skill in the art. Features,elements, and aspects described herein may also be combined or replacedby alternative features serving the same, equivalent, or similar purposewithout departing from the scope of the invention defined by theappended claims.

1.-31. (canceled)
 32. A dressing assembly for providingnegative-pressure therapy to a tissue site, the dressing assemblycomprising; a pouch; a cover configured to cover the pouch; anegative-pressure source having resilient walls fluidly coupled to thepouch, the negative-pressure source having a first position and a secondposition; a first check valve fluidly coupled to the pouch and thenegative-pressure source and operable to prevent fluid flow from thenegative-pressure source into the pouch if the negative-pressure sourceis moved from the second position to the first position; and a secondcheck valve fluidly coupled to the negative-pressure source and theambient environment and configured to prevent fluid flow from an ambientenvironment into the negative-pressure source if the negative-pressuresource is moved from the first position to the second position.
 33. Thedressing assembly of claim 32, wherein: the pouch is coupled to thecover, the cover having a periphery extending beyond an edge of thepouch; the negative-pressure source is coupled to the cover; and thedressing assembly further comprises a tube fluidly coupling the pouch tothe negative-pressure source through the cover, wherein the first checkvalve is disposed in the tube.
 34. The dressing assembly of claim 33,wherein the pouch and the negative-pressure source are coupled to a sameside of the cover.
 35. The dressing assembly of claim 33, wherein thepouch and the negative-pressure source are coupled to opposite sides ofthe cover.
 36. The dressing assembly of claim 33, wherein the peripheryof the cover further comprises: a barrier layer; a bonding adhesivelayer coupled to the barrier layer; and a sealing adhesive layer havinga plurality of apertures and coupled to the barrier layer, the bondingadhesive layer is configured to extend at least partially through theplurality of apertures in the sealing adhesive layer in response toforce applied to the barrier layer.
 37. The dressing assembly of claim36, wherein the bonding adhesive layer and the sealing adhesive layerare registered with each other.
 38. The dressing assembly of claim 36,wherein the sealing adhesive layer is coupled to the bonding adhesivelayer.
 39. The dressing assembly of claim 32, wherein thenegative-pressure source comprises: a source cavity; a foam blockdisposed in the source cavity and configured to bias thenegative-pressure source to the second position.
 40. The dressingassembly of claim 39, wherein the source cavity comprises a filmsurrounding the foam block.
 41. The dressing assembly of claim 39,further comprising a film coupled to the cover to form the sourcecavity.
 42. The dressing assembly of claim 39, wherein the coverincludes a plastically deformed portion configured to form a cavitycontaining the negative-pressure source.
 43. The dressing assembly ofclaim 39, wherein the foam block is an open-cell reticulated foam havinga compressive force deflection greater than about 2 kilo Pascals. 44.The dressing assembly of claim 43, wherein the foam block has acompressive force deflection greater than about 4 kilo Pascals.
 45. Thedressing assembly of claim 39, wherein the foam block comprises: a firstfoam block having a first compressive force deflection; and a secondfoam block having a second compressive force deflection.
 46. Thedressing assembly of claim 32, further comprising a tissue interfaceconfigured to be positioned between the tissue site and the pouch. 47.The dressing assembly of claim 46, wherein the negative-pressure sourcecomprises: a source cavity; a foam block disposed in the source cavityand configured to bias the negative-pressure source to the secondposition; and wherein a compressive force deflection of the foam blockdisposed in the source cavity is greater than a compressive forcedeflection of the tissue interface.
 48. The dressing assembly of claim46, wherein the tissue interface is less than 10 millimeters thick. 49.The dressing assembly of claim 46, wherein the tissue interfacecomprises a manifold.
 50. The dressing assembly of claim 46, wherein thetissue interface comprises a gauze.
 51. The dressing assembly of claim32, wherein the pouch further comprises: an upstream layer; an absorbentdisposed adjacent to the upstream layer; and a downstream layer disposedadjacent to the absorbent, the upstream layer and the downstream layerhaving peripheral portions coupled to each other to enclose theabsorbent.
 52. The dressing assembly of claim 51, wherein the upstreamlayer and the downstream layer each comprise a non-woven material havingan area density between about 80 grams per square meter and about 100grams per square meter.
 53. The dressing assembly of claim 32, whereinthe cover comprises a hybrid drape.
 54. The dressing assembly of claim32, wherein the cover comprises: a barrier layer; a bonding adhesivelayer coupled to the barrier layer; and a sealing adhesive layer havinga plurality of apertures and coupled to the bonding adhesive layer, thebonding adhesive layer is configured to extend at least partiallythrough the plurality of apertures in the sealing adhesive layer inresponse to force applied to the barrier layer.
 55. The dressingassembly of claim 32, further comprising a filter disposed in a fluidpath between the first check valve and the negative-pressure source. 56.The dressing assembly of claim 55, wherein the filter comprises ahydrophobic porous polymer.
 57. The dressing assembly of claim 55,wherein the filter includes gel-blocking properties.
 58. The dressingassembly of claim 32, wherein the negative-pressure source has a largervolume than the pouch.
 59. The dressing assembly of claim 46, whereinthe negative-pressure source has a larger volume than a combined volumeof the pouch and the tissue interface.
 60. The dressing assembly ofclaim 32, wherein the negative-pressure source is configured to provide70 millimeters of mercury of negative pressure to the tissue site.61.-67. (canceled)
 68. An apparatus for providing negative-pressuretherapy to a tissue site, the apparatus comprising: a barrier layer, abonding adhesive layer coupled to the barrier layer, and a sealingadhesive layer configured to be coupled to the tissue site and thebarrier layer, the sealing adhesive layer having a plurality ofapertures, the bonding adhesive layer configured to extend at leastpartially through the plurality of apertures in the sealing adhesivelayer; and a blister coupled to the barrier layer and configured to befluidly coupled to the tissue site, the blister comprising, a film layerconfigured to be coupled to the barrier layer and form a source cavity,and a foam block disposed in the source cavity, the foam block having anexpanded position and a collapsed position.